VIVIT - Medical Face Mask - Ties, Soft, Dye Free, Anti - 1. Vivit International Inc

Duns Number:815240958

Device Description: Medical Face Mask - Ties, Soft, Dye Free, Anti Fog-Foam, White, 80mm Hg ASTM Level 1

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More Product Details

Catalog Number

-

Brand Name

VIVIT

Version/Model Number

11215TM

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

26e9b281-7277-4365-99b3-7e43fab5f4dc

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 30, 2021

Additional Identifiers

Package DI Number

20810084210141

Quantity per Package

6

Contains DI Package

10810084210144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case