Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10547

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K934969,K934969,K934969

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

103f630a-6830-442f-93e4-0301548186b2

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Package DI Number

20368001105471

Quantity per Package

4

Contains DI Package

00368001105477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-