Catalog Number

BRL280

Brand Name

Aero-Med

Version/Model Number

BRL280

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

47e6c4ac-3bd1-4ba5-a720-3d36d8882b62

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2019

Package DI Number

50810010890561

Quantity per Package

10

Contains DI Package

10810010890563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE