Catalog Number

AMS-610

Brand Name

VYGON

Version/Model Number

AMS-610

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

K884370,K884370

Product Code

FPK

Product Code Name

Tubing, fluid delivery

Public Device Record Key

b53d664e-c902-4923-bd94-a4fcd777e98e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 28, 2017

Package DI Number

38498840010281

Quantity per Package

50

Contains DI Package

08498840010280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-