QD Syringe | QD Syringe Systems®

Posted on October 1, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , , , |

qd-syringe-systems-quick-draw-syringe-with-low-residual-volume

Low Dead Space QD Syringe with Low Residual Volume QD Hub with Needle.

 

qd-syringe-systems-low-dead-space-syringe

QD Syringe accessing BD Q-Syte and delivering low residual volume dose.

 

 qd-syringe-systems-low-dead-space-injection

QD Syringe giving low dead space intramuscular injection with QD hub and needle.

 

qd-syringe-systems-hep-lock-access

Hep Lock Accessed by low dead space QD Syringe with Integrated polycarbonate cannula.

 

qd-syringe-photo-low-dead-space-and-residual-volume-injection

QD Syringe injecting medication with low dead space, low residual volume. http://www.QDSyringe.com

 

qd-syringe-low-dead-space-injection-syringe

QD Syringe – Low Dead Space Injection Syringe – QD Syringe before patient injection with the low dead space syringe offering a virtually painless injection. – http://www.QDSyringe.com

 

qd-syringe-the-low-space-syringe

QD Syringe was designed as a low residual volume syringe with an integrated polycarbonate draw needle and an exclusive mating low dead space hub and needle. The next generation of basic disposable syringes. http://www.QDSyringeSystems.com

 

qd-syringe-suture-removal-assistance

The QD syringe can assist in removing embedded sutures by wedging beneath the sutures and the overgrown skin enabling the scalpel or scissors to cut the suture and not the patient. Note: There are suture removal kits but they are more costly than the disposable QD Syringe and a scalpel. http://www.QDSyringeSystems.com

 

qd-syringe-qd-hubs-and-needles

 

Low Dead Space QD Hubs and Sharp Steel Needles delivering virtually painless injections – http://www.QDSyringe.com

 

 

qd-syringe-qd-hubs

 

QD Syringe Systems – The low dead space QD Hubs with needles mate with the tip of the QD Syringe providing a low waste syringe.

 

qd-syringe-low-residual-volume-syringe

 

The QD Syringe is the world’s first fully functional basic plastic syringe with low dead space.

 

 

qd-syringe-low-residual-volume-syringe-with-glyflo-technology

The QD Syringe incorporates a polypropylene syringe body and a contiguously integrated polycarbonate tip with GlyFlo Technology to deliver a low residual volume injection. The worlds first truly functional basic plastic syringe. The QD Syringe eliminates all draw needles which waste medications and contribute to inadvertent needle stick injuries by medical staff and patients. http://www.QDSyringe.comhttp://www.QDSyringeSystems.com

 

 

qd-syringe-low-dead-space-injection

QD Syringe giving low dead space, low residual volume injection. The QD syringe is a patented syringe which consists of a polypropylene syringe body and a polycarbonate tip designed with GlyFlo Technology. The QD Syringe tip mates with the low dead space QD hub with attached steel needle to deliver a precisely measured medication dose. the QD Syringe delivers virtually a pain free injection.

 

qd-syringe-glyflo-technology

 

QD Syringe giving low dead space, low residual volume injection. The QD syringe is a patented syringe which consists of a polypropylene syringe body and a polycarbonate tip designed with GlyFlo Technology. The QD Syringe tip mates with the low dead space QD hub with attached steel needle to deliver a precisely measured medication dose. the QD Syringe delivers virtually a pain free injection. http://www.QDSyringeSystems.comhttp://www.QDSyringe.com

 

 

qd-syringe-glyflo-technology-accessing-bd-q-syte-split-septum-luer

The QD Syringe with GlyFlo Technology is accessing BD QSyte Split Septum Luer with low residual volume, low dead space medication delivery. http://www.QDSyringeSystems.comhttp://www.QDSyringe.com

 

qd-syringe-accessing-hep-lock

QD Syringe Accessing Halkey-Roberts Needlefree Swabable Valve and delivering a low residual volume injection.

 

 

qd-syringe-systems-quick-draw-syringe

QD Syringe Systems – The Low Dead Space Multi-Functional Syringe.

 

 

qd-syringe-accessing-bd-q-syte-split-septum-luer

QD Syringe – accessing the BD Q-Syte™ Luer Access Split Septum and leaving low residual volume in syringe ~ http://www.QDSyringeSystems.com

——————-

The QD Syringe has been touted as the next generation of safer and more effective syringes to enter the market – the Quick Draw Syringe™. The Quick Draw Syringe or the QD Syringe is a revolutionary product that will be the world’s first fully functional basic low dead space syringe with detachable and low residual volume QD hubs with needles.

Created by Christopher Green, CEO and co-founder of QD Syringe Systems Inc., this patented eco-friendly product is unique in the fact that it is fully functional out of its package, it is safer and easier for medical professionals to use and a low dead space syringe that tremendously reduces medication waste and residual volume. Headquartered in St. Petersburg, Florida, QD Syringe Systems, Inc. CEO says the design of basic syringe hasn’t been updated in decades. Until now. Introducing the QD Syringe.

http://www.QDSyringe.com
http://www.QDSyringeSystems.com

 

__________________

Advertisements
Read Full Post | Make a Comment ( None so far )

QD Syringe – The Low Dead Space Syringe

Posted on September 29, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , |

qd-syringe-with-bilateral-glyflo-technology-1

The QD Syringe drastically cuts the waste of costly medications down by over 89%, leaving just a scant 18 microliters of residual volume behind. This is a massive money-saving benefit to the healthcare industry and consumers.

Christopher Green designed the Bilateral QD GlyfloTechnology™ for the QD Syringe. The uniquely patented cone-shaped tip has bilateral fluid flow channels and a bilateral orifice. This new design also greatly reduces the risks of needle sticks by medical professionals, reduces the spread of infectious diseases, and saves tremendously on medication waste with its low residual volume design and guarantees delivering a less painful injection to the patient.

The Low Dead Space Syringe – Low Residual Volume Syringe

Syringe with Integrated Cannula – Patent # 9,295,788

 

Read Full Post | Make a Comment ( None so far )

510k Premarket Notification Fees

Posted on June 5, 2012. Filed under: Syringe Blog | Tags: , , , , , , |

Premarket Notification 510k Review Fees

Overview

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 signed into law. This law authorizes FDA to charge a fee for medical device Premarket Notification 510(k) reviews. This application fee applies to most 510(k)s including Traditional, Abbreviated, and Special 510(k)s, but not those exempted or waived as noted below.

Small businesses may qualify for a reduced fee. Payment must be received on or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

FOLLOW US ON TWITTER

Fees

The review fees for 510(k) submissions are below:

FY 2012 Device Review User Fees (U.S. Dollars)
Submission Standard Fee Small Business Fee
(≤$100 million in gross receipts or sales)
510(k) $4,049 $2,024
513(g) $2,971 $1,485

The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The small business fee is 50% of the standard fee. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

 Exemptions and Waivers

The following exemptions or waivers apply:

Fee Exemptions and Waivers (No Fee for These)
Category Exemption or Waiver
Third-party 510(k) Exempt from any FDA fee; however, the third-party does charge a fee for its review.
Any application for a device intended solely for pediatric use. Exempt from user fee. Please note that changing the intended use from pediatric use to adult use requires the submission of a new 510(k). The new 510(k) is subject to the 510(k) review fee at the time of submission.
Any application from a State or Federal Government entity. Exempt from any fee unless the device is to be distributed commercially.

When to Pay

Payment must be received at or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

 How/Where to Send Payment

Submit the information and payment in the following order
  1. If you believe you qualify as a Small Business and would like to qualify for reduced fees, submit a Small Business Qualification Certification. If you qualify, you will receive a Small Business Decision number. You must provide your Small Business Decision number on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
  2. Complete the Medical Device User Fee Cover Sheet and send a completed copy with your payment.
  3. Submit your Premarket Notification 510(k) and include a copy of the Medical Device User Fee Cover Sheet with your submission.
  4.  Complete the Medical Device User Fee Cover Sheet
 

You should complete the Medical Device User Fee Cover Sheet (Form FDA-3601). The Medical Device User Fee Cover Sheet and instructions are available online.

You will need to register to create a Medical Device User Fee Cover Sheet. Please note that the User Fee Cover Sheet website was enhanced on March 1, 2005. Even if you have registered in the User Fee Cover Sheet system previously to March 1, 2005, you will need to follow the instructions as a “New User.”

You will need one of the following pieces of information to complete the registration process.

Organization #: 123456
Dun and Bradstreet Number (DUNS) # 123456789
Employer Identification Number (EIN) #  123456789

Additionally, you will need to identify a Principal Point of Contact (PPOC) in your organization who will be responsible for validating users for security purposes.

After you have registered and have created a user name and password, you will receive a confirmation email. You may then access the cover sheet creation page. A unique user fee Payment Identification Number will be generated on your cover sheet upon completion. You will need three copies of your completed User Fee Cover Sheet: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.

Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

Submit Your Payment

Send a printed copy of your User Fee Cover Sheet with your payment. Be sure to include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on your check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer.

Send your payment to:

By Mail:
Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733By Courier: If the check is sent by a courier, the courier may deliver the checks to:
US Bank
Attn: Government Lockbox 956733
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. Contact the US Bank at (314) 418-4821 if you have any questions concerning courier delivery.)

By Wire Transfer:

“As of 1/31/10 US Bank will no longer accept Wire Transfers”
Wire transfers are now processed through the Federal Reserve Bank of New York. You will need the following information to remit a payment:

FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit Number or ABA: 021030004
Address:
Federal Reserve Bank of New York
TREAS NYC
33 Liberty Street
New York, NY 10045
Tel (212) 720-5000
Also include your User Fee Payment Identification Number from your Medical Device User Fee Cover sheet when you send payment by wire transfer.Note: Your bank or financial institution may assess a fee for sending a wire transfer.
If needed for accounting purposes, FDA’s tax identification number is 53-0196965.
Fees should arrive at the bank at least 1 day before the application arrives at FDA. FDA recommends that you send the payment to the bank 4-5 business days before the application arrives at FDA so there is no delay in starting the review of your application. FDA records as the submission receipt date the latter of the following:1. The date the submission was received by FDA; or
2. The date Bank notifies FDA that payment has been received.
Bank is required to notify FDA within 1-working day, using the Payment Identification Number.

 Qualification for Small Business Fees

In FY2012 (October 1, 2011 through September 30, 2012), firms with annual gross sales and revenues with $100 million or less, including gross sales and revenues of all affiliates, partners, and parent firms, may qualify for lower rates for Premarket Notification 510(k) submissions.

An affiliate is defined by §737(8) of the FD&C Act: An affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly,

  1. one business entity controls, or has the power to control, the other business entity; or
  2. a third party controls, or has power to control, both of the business entities.

 

To qualify, you must submit the MDUFMA Small Business Qualification Certification (Form FDA 3602). In addition, certified copies of your firm’s Federal Income Tax Return for the most recent taxable year, including certified copies of the income tax returns of all affiliates, partners, and parent firms must be provided.

The following guidance and form should be used.

FY2012 MDUFMA Small Business Qualification Worksheet and Certification

The Certification should be sent to:

MDUFMA Small Business Qualification
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
10903 New Hampshire Avenue, WO66-4613
Silver Spring, MD 20993

FDA will review the Certification within 60 days and send its decision that the firm is, or is not, a small business eligible for reduced or waived fees. If your firm qualifies as a small business, the decision letter will include a Small Business Decision number. The Small Business Decision number is used on the Medical Device User Fee Cover Sheet (Form FDA 3601) to demonstrate that your firm is entitled to a reduced fee. If you submit a reduced fee to FDA without a Small Business Decision number, the submission will not be accepted for filing.

The small business status expires at the end of each fiscal year (September 30th). A new MDUFMA Small Business Qualification Certification must be submitted each year to qualify as a small business.

Questions concerning Small Business Qualification should be directed to Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at 301-796-7100 (800-638-2041).

_____________________

(Source: www.FDA.gov)
________________

www.QDSyringeSystems.com
www.Twitter.com/QDSyringe
www.Syringes.co

Read Full Post | Make a Comment ( None so far )

510k Frequently Asked Questions

Posted on May 29, 2012. Filed under: Syringe Blog | Tags: , , , , |

510k  Q & A

Distributors

I would like to distribute a manufacturer’s product under my own company name. Do I need to submit a 510(k)?

FOLLOW US ON TWITTER

 

No, the manufacture should submit the 510(k), if required for the device. As required under 21 CFR 801.1(c), where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ABC Company,” “Distributed by ABC Company,” or any other wording that expresses the facts.  The distributor should forward all product complaints to the manufacturer for evaluation in accordance with 21 CFR 820.198 Complaint files.

Foreign Manufacturers

 

Can foreign companies submit a Premarket Notification 510(k)?

Yes. The foreign manufacturer may submit a 510(k) directly to FDA. For convenience, a foreign manufacturer may receive assistance from a U.S. entity and may use a contact person residing in the U.S.

Registration

 

Do I need to register my facility before I submit a 510(k)?

No. If you are a new company and do not manufacture any medical devices, you should not register until you are within 30 days of manufacturing and distributing the device. The 510(k) submission should state that you are not currently registered. Information on how to register your facility is available at Registering Your Establishment.

Quality System

 

Do I need to provide documentation that my facility complies with the Quality System in my 510(k)?

No. However, if you are submitting a Special 510(k), you must provide declaration of conformity with the design controls aspect of the Quality System.

Do I need to have my facility inspected to the Quality System regulations before I submit a 510(k)?

No. There is no pre-approval inspection as a prerequisite to 510(k) clearance. However, you should be prepared for an FDA inspection at any time.

____________________

Source ~ www.FDA.org

________________
Read Full Post | Make a Comment ( None so far )

Low “Dead Space” Syringes Could Save Your Life

Posted on February 2, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , |

Another guest article from Jamie Bridge this week. This time he’s writing about some of the work of researcher Dr. William Zule, looking into how the type of syringe someone uses may have an inpact on their risk of getting the HIV virus. I have had this article a few weeks but it was embargoed until the AIDS2010 conference started as its finding are being presented there.

How syringe type effects HIV risk

New research being presented this week at the International AIDS Conference in Vienna has made a strong link between different types of syringe and levels of HIV transmission through sharing.

Every needle-syringe, when the plunger is fully depressed, retains some fluid or blood in what is termed “dead-space”. Some syringe designs have more of this “dead space” than others – especially those with detachable needles. Depending on the design, some syringes can retain 84 microlitres of fluid. This is a very, very small amount – but other syringe designs can retain as little as 2 microlitres.

So the hypothesis is simple: if you share a syringe with higher “dead-space”, then there will be more blood retained in the syringe and you will be more likely to become infected with blood-borne viruses. If you share a low “dead space” syringe, you are still putting yourself at risk – but perhaps less so, as there is less blood retained when the plunger is fully down.

Previous modelling work by Dr William Zule and colleagues in the USA tried to quantify what this could mean in the real world. The results suggested that injection-related HIV epidemics might not occur when most (95% or more) of injectors use syringes with low “dead space”. If everyone uses higher “dead space” syringes, then HIV prevalence can reach 50% among injectors in just seventeen years. When just one in ten sharing events involve high “dead space” syringes, then HIV prevalence can stabilise.

The findings, albeit theoretical, have clear implications for harm reduction programs. However, in Vienna, the research has been taken to the next level. Data from multi-year HIV prevalence studies were gathered from 35 cities in 20 countries, and local needle exchange workers were contacted to find out what types of syringe were mainly used.

In cities where high “dead space” syringes were mainly used, the average HIV prevalence among injectors was 32.6% (and went up as high as 73%). In cities where low “dead space” syringes were mainly used, the average was just 1.4%. When the data were analyzed, the type of syringe was the only factor closely associated with this pattern in HIV.

More research needs to be done on this topic, and expect to hear a lot more about this in the future – this is an important finding which could have a big impact on harm reduction and the advice given to injectors. Of course, the biggest message is that ALL needle-syringe sharing is a risk. However, if we could reduce HIV transmission simply by providing one kind of syringe over another, then this is something that must be rolled out as soon as possible. Do you know what kind of syringe your local exchange supplies?

A big thank you to Dr William Zule for sharing this research.

Jamie Bridge, MSc, currently works in the Technical Publications and Learning Team of the Global Fund to Fight AIDS, Tuberculosis and Malaria. Before moving to Geneva in 2010, he worked for the International Harm Reduction Association in London, coordinating the international harm reduction conferences. Before that, he also worked in a needle and syringe program in Bedford. Jamie also works voluntarily with UKHRA and the NNEF.

——-

www.QDSyringeSystems.com
www.QDSyringe
www.Twitter.com/QDSyringe
www.Syringes.co

 

Read Full Post | Make a Comment ( 1 so far )

Liked it here?
Why not try sites on the blogroll...