AccessGUDID - DEVICE: Movement and Compressions System (MAC) (B547RF14220)

GUDID

Device Identifier (DI) Information

Brand Name: Movement and Compressions System (MAC)
Version or Model: 4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RF1422
Company Name: Recovery Force, LLC

Primary DI Number: B547RF14220
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079413560 *Terms of Use

Device Description: MAC Strap-Bariatric

Device Characteristics

What MRI safety information does the labeling contain?	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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10969	Intermittent venous compression system	A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 921 Millimeter

Device Record Status

Public Device Record Key: d0f9e9ad-b516-4034-b58f-b31c5c38fd28
Public Version Date: January 20, 2023
Public Version Number: 9
DI Record Publish Date: May 07, 2021