Catalog Number

60500010100

Brand Name

A.T.S.® Personalized Pressure®

Version/Model Number

60-5000-101-00

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

-

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

K202919

Product Code

KCY

Product Code Name

TOURNIQUET, PNEUMATIC

Public Device Record Key

b2c48c54-c626-4b9e-a98c-131d59779271

Public Version Date

April 07, 2022

Public Version Number

1

DI Record Publish Date

March 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-