Catalog Number

QFT 200

Brand Name

Quick Fill Disposable Syringe Fill Tube

Version/Model Number

QFT 200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K800823,K800823

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

00d63e03-1188-4f16-8300-9da87a8b51b8

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 25, 2019

Package DI Number

40616258022008

Quantity per Package

100

Contains DI Package

00616258022000

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-