Catalog Number

-

Brand Name

Compressible Limb Therapy System(MK300L)

Version/Model Number

ACg0615

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

K112441,K112441

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

cb6e67f3-a000-479c-8651-7db30932426b

Public Version Date

July 18, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2016

Package DI Number

18809315679043

Quantity per Package

3

Contains DI Package

08809315679046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX