Catalog Number

-

Brand Name

Ombra®

Version/Model Number

Compressor Kit, DME, Adult

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

-

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

69fe10b0-9701-4e90-8342-5e4004f9aa98

Public Version Date

September 09, 2021

Public Version Number

2

DI Record Publish Date

August 15, 2018

Package DI Number

50604351637011

Quantity per Package

1

Contains DI Package

00604351637016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-