Ombra® - Monaghan Medical Corporation

Duns Number:056332380

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More Product Details

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

Product Characteristics

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 Details

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Device Record Status

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

Additional Identifiers

Package DI Number

50604351637011

Quantity per Package

1

Contains DI Package

00604351637016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MONAGHAN MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 39