Amerishield - Premium-PPE Amerishield Surgical Mask, ASTM Level - Premiumestore, LLC

Duns Number:014851503

Device Description: Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Outer Case of 2,000 Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Outer Case of 2,000 Masks, 40 inner boxes per case, K211520

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More Product Details

Catalog Number

-

Brand Name

Amerishield

Version/Model Number

PPE-M-AS-SUR-LVL2-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

K211520

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

d2ae2327-8050-4c12-9fc5-208252f987ae

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 24, 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