CYPRESS - Pneumatic Oxygen Conserver - INOVO, INC.

Duns Number:015954530

Device Description: Pneumatic Oxygen Conserver

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More Product Details

Catalog Number

-

Brand Name

CYPRESS

Version/Model Number

OM-501A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2021

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

NFB

Product Code Name

Conserver, Oxygen

Device Record Status

Public Device Record Key

3e0deca4-668a-4dcd-b891-26d14b473b46

Public Version Date

October 18, 2021

Public Version Number

4

DI Record Publish Date

January 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INOVO, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 29