Catalog Number

QUE2475

Brand Name

Aero-Med

Version/Model Number

QUE2475

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

19fe2015-5073-47bf-9a08-eef178859a5a

Public Version Date

December 01, 2020

Public Version Number

1

DI Record Publish Date

November 23, 2020

Package DI Number

50810010892992

Quantity per Package

50

Contains DI Package

00810010892997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE