Catalog Number

AMS-750

Brand Name

VYGON

Version/Model Number

AMS-750

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

Yes

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

b4ab5bab-c0a6-42e1-9078-2e23e557ef9f

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Package DI Number

30849884001984

Quantity per Package

20

Contains DI Package

00849884001983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-