Catalog Number

AMM055

Brand Name

Aero-Med

Version/Model Number

AMM055

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"

Yes

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

da8bf360-1227-4627-adae-de06da2f4b1a

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

March 27, 2019

Package DI Number

50810010891018

Quantity per Package

100

Contains DI Package

10810010891010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE