NOVAPLUS - Novaplus ASTM Fluid-Rated Procedure Mask, Blue - O&M HALYARD, INC.

Duns Number:081057389

Device Description: Novaplus ASTM Fluid-Rated Procedure Mask, Blue

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

47595

Brand Name

NOVAPLUS

Version/Model Number

47595

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

Yes

Prescription Use (Rx)

-

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

FXX

Product Code Name

Mask, surgical

Device Record Status

Public Device Record Key

44912e5c-66ef-4c44-b990-ceec52ee8716

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

May 16, 2019

Additional Identifiers

Package DI Number

30680651475955

Quantity per Package

10

Contains DI Package

20680651475958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"O&M HALYARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 1044