Catalog Number

AMM5000

Brand Name

Aero-Med

Version/Model Number

AMM5000

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

1a752da6-7281-4064-b72b-ceca760e0ae0

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

50810010893074

Quantity per Package

50

Contains DI Package

00810010893079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE