Catalog Number

A201C-4200-10

Brand Name

ActiveCare

Version/Model Number

ActiveCare calf sleeve X-Large pair

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

K151377,K151377,K151377

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

5c115433-c22b-4abb-b0d4-271b36d2f391

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

January 05, 2018

Package DI Number

27290016525469

Quantity per Package

10

Contains DI Package

07290016525465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-