Catalog Number

BRL255

Brand Name

Aero-Med

Version/Model Number

BRL255

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

c54b4930-ca6f-4fcb-9493-35c679a4dfc0

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

March 27, 2019

Package DI Number

50810010890547

Quantity per Package

288

Contains DI Package

10810010890549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE