Catalog Number

10554494001

Brand Name

OMBRA Compressor Air Filters

Version/Model Number

105544

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2020

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131881,K131881

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

77f3de87-839e-45b8-93a9-9c0823f0cdd7

Public Version Date

April 23, 2020

Public Version Number

5

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-