Amerishield - Premium-PPE Amerishield AirMax Procedure Mask, - Premiumestore, LLC

Duns Number:014851503

Device Description: Premium-PPE Amerishield AirMax Procedure Mask, ASTM Level 3, 4-Ply Adult Blue, Outer Case Premium-PPE Amerishield AirMax Procedure Mask, ASTM Level 3, 4-Ply Adult Blue, Outer Case of 2,000 Masks, 40 inner boxes per case, K211275

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More Product Details

Catalog Number

-

Brand Name

Amerishield

Version/Model Number

PPE-M-AS-SUR-S

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

1c52a5b1-d279-413f-843e-a156a66d3f6e

Public Version Date

July 01, 2022

Public Version Number

1

DI Record Publish Date

June 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PREMIUMESTORE, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4