Catalog Number

-

Brand Name

1MED

Version/Model Number

1MED-33LSM1

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

fd8657a5-9e02-49d7-87f6-008151d736a1

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

May 01, 2022

Package DI Number

10850039859479

Quantity per Package

20

Contains DI Package

00850039859472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case