Innova Nasal Non Vented Mask, s/m - Nasal non vented mask for use with non invasive - SLEEPNET, CORP.

Duns Number:785635186

Device Description: Nasal non vented mask for use with non invasive ventilator system with exhalation valve.

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More Product Details

Catalog Number

-

Brand Name

Innova Nasal Non Vented Mask, s/m

Version/Model Number

50592

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"

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

-

Product Code Details

Product Code

BYG

Product Code Name

Mask, Oxygen

Device Record Status

Public Device Record Key

bdce862d-ece8-463a-ae05-a879a8d2e1a9

Public Version Date

May 01, 2019

Public Version Number

1

DI Record Publish Date

April 23, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SLEEPNET, CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 217