Mueller Sports Medicine

Basic Information

• Brand Name: Mueller Sports Medicine
• Primary DI: 00074676007014
• Version / Model: M2RG200LG
• Catalog Number: M2RG200LG
• Company Name: Mueller Sports Medicine, Inc.
• Labeler DUNS: 006426316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 1
• Public Version Date: 2022-09-08
• Public Version Status: New
• Public Device Record Key: 90bba577-f935-454a-93bd-7c924a463278

Device Description

M2 Gear Pack LG

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRP	Massager, powered inflatable tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00074676007014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163280	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Degrees Celcius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 66 Degrees Celsius