Catalog Number

-

Brand Name

America's Best Care

Version/Model Number

3050-2-ABC

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003344,K003344

Product Code

BTI

Product Code Name

Compressor, air, portable

Public Device Record Key

aec4b17f-4289-4249-8ad2-b06656420b27

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10822383295036

Quantity per Package

10

Contains DI Package

00822383295039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-