MEDICOM ASSUREMASK VALIANT - ASSUREMASK - PROCEDURE EARLOOP FACE MASK - LEVEL - AMD Medicom Inc

Duns Number:256880576

Device Description: ASSUREMASK - PROCEDURE EARLOOP FACE MASK - LEVEL 2 - BLUE

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More Product Details

Catalog Number

205815

Brand Name

MEDICOM ASSUREMASK VALIANT

Version/Model Number

205815

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)

Yes

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

d8f39162-e6b5-4318-88d2-46e85ed0044d

Public Version Date

April 27, 2022

Public Version Number

2

DI Record Publish Date

June 17, 2021

Additional Identifiers

Package DI Number

20686864057486

Quantity per Package

10

Contains DI Package

10686864057489

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE

"AMD MEDICOM INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 2