Catalog Number

AMS-8508CP-4

Brand Name

VYGON

Version/Model Number

AMS-8508CP-4

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

OWL

Product Code Name

Peripheral catheter insertion kit

Public Device Record Key

81ba1b28-5392-4ef6-9a45-e9dde115f7e6

Public Version Date

February 05, 2021

Public Version Number

1

DI Record Publish Date

January 28, 2021

Package DI Number

30849884005395

Quantity per Package

30

Contains DI Package

00849884005394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-