Catalog Number

AMS-8034CP

Brand Name

VYGON

Version/Model Number

AMS-8034CP

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

f7fb7543-b6be-46b2-ac24-05b3fe83d171

Public Version Date

February 18, 2020

Public Version Number

1

DI Record Publish Date

February 10, 2020

Package DI Number

30849884003483

Quantity per Package

10

Contains DI Package

00849884003482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-