AccessGUDID - DEVICE: Mueller Sports Medicine (00074676007168)

GUDID

Device Identifier (DI) Information

Brand Name: Mueller Sports Medicine
Version or Model: RG500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RG500
Company Name: Mueller Sports Medicine, Inc.

Primary DI Number: 00074676007168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006426316 *Terms of Use

Device Description: REVIVE ARM SLEEVE GRAY

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
16837	Sequential 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 applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRP	Massager, powered inflatable tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163280	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 -20 and 66 Degrees Celsius
Special Storage Condition, Specify: Degrees Celcius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85710e71-683e-467c-bc33-fea3e6ecb1c2
Public Version Date: March 31, 2025
Public Version Number: 3
DI Record Publish Date: August 31, 2022