Catalog Number

AMS-626TGSLF

Brand Name

VYGON

Version/Model Number

AMS-626TGSLF

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRS

Product Code Name

I.V. start kit

Public Device Record Key

6da643e0-ab4c-4a61-86d4-fee7a1235ba6

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

August 25, 2016

Package DI Number

38498840001777

Quantity per Package

50

Contains DI Package

08498840001776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-