Catalog Number

A201T248010

Brand Name

ActiveCare

Version/Model Number

ActiveCare Thigh sleeve large

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

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

1ba4fb8c-d761-4c87-abea-4894a09237d3

Public Version Date

June 18, 2019

Public Version Number

1

DI Record Publish Date

June 10, 2019

Package DI Number

00889024505001

Quantity per Package

6

Contains DI Package

00889024504882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case