Catalog Number

A502B-0002-01

Brand Name

ActiveCare

Version/Model Number

HomeCare ActiveCare+S.F.T

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

K060146,K151377,K060146,K151377,K060146,K151377,K060146,K151377

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

c5731ef9-eaa7-4b4c-8489-68270a6dd274

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 04, 2017

Package DI Number

37290016525398

Quantity per Package

12

Contains DI Package

17290016525394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-