Catalog Number

AM3979

Brand Name

NH3

Version/Model Number

AM3979

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030873

Product Code

JIF

Product Code Name

Enzymatic Method, Ammonia

Public Device Record Key

4d9ae5c7-4ab1-45f8-a0d7-7294d6df48d2

Public Version Date

January 24, 2019

Public Version Number

1

DI Record Publish Date

December 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-