Catalog Number

-

Brand Name

blox

Version/Model Number

BLX-9501

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"

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

MSH

Product Code Name

Respirator, Surgical

Public Device Record Key

58232524-77ef-4f1f-a3d4-055fb4453a2e

Public Version Date

November 19, 2021

Public Version Number

1

DI Record Publish Date

November 11, 2021

Package DI Number

00814088020788

Quantity per Package

50

Contains DI Package

00814088020726

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box