Catalog Number

RF1423

Brand Name

Movement and Compressions System (MAC)

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

K203052,K203052

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

5b13eb78-6b00-448d-9ca7-98b032fce2a2

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 10, 2022

Package DI Number

B547RF14237

Quantity per Package

24

Contains DI Package

B547RF14230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box