Catalog Number

-

Brand Name

OMBRA 120V Table Top Compressor System

Version/Model Number

105510

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

-

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

K131881,K131881,K131881

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

f0d40ade-f277-48c0-94a6-ed409b9781dd

Public Version Date

April 02, 2020

Public Version Number

1

DI Record Publish Date

March 25, 2020

Package DI Number

10762860055107

Quantity per Package

6

Contains DI Package

00762860055100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-