Resilient Medical Solutions - ASTM Level Earloop Mask with Anti-Fog Foam, Violet - Resilient Medical Solutions, LLC

Duns Number:076404432

Device Description: ASTM Level Earloop Mask with Anti-Fog Foam, Violet

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More Product Details

Catalog Number

-

Brand Name

Resilient Medical Solutions

Version/Model Number

RMEM3F

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

41655835-d73f-47ce-adce-620cb9be2792

Public Version Date

June 22, 2022

Public Version Number

1

DI Record Publish Date

June 14, 2022

Additional Identifiers

Package DI Number

10850037100078

Quantity per Package

10

Contains DI Package

00850037100071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"RESILIENT MEDICAL SOLUTIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9