Catalog Number

BL6155BEN

Brand Name

Critical Cover

Version/Model Number

BL6155BEN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

228c45ae-5751-4417-815c-678ea79ce4ce

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

November 15, 2016

Package DI Number

20817583020592

Quantity per Package

10

Contains DI Package

10817583020595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE