Catalog Number

5921218235R

Brand Name

Medline

Version/Model Number

5921218235R

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCY

Product Code Name

TOURNIQUET, PNEUMATIC

Public Device Record Key

269109c4-ffab-4c2b-ba23-f04f4639501c

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

40888277386571

Quantity per Package

10

Contains DI Package

10888277386570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE