ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113681795
• Version / Model: PlasmaWave
• Catalog Number: PWAVE01
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-01
• Public Version: 1
• Public Version Date: 2022-07-11
• Public Version Status: New
• Public Device Record Key: 14bd3ea2-d265-48d4-83bd-a4880f7e429c

Device Description

The PlasmaWave is a game changing portable pneumatic SCD device used in the home or clinical setting. It carries a market leading 25+ hour battery and two calf sleeves. Portable and lightweight Long lasting re-chargeable battery - up to 26 hours of use on one charge 2 Modes: Slow inflation and Step-Up Technology which allows the unit to increase pressure in slower increments 1 LCD screen to monitor usage, pressure, and battery life Hospital or surgery center conversion kit - over 8ft of reusable tubing, disposable SCD sleeves, and a stationary bed rack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
64438	Compression/pressure tubular garment	A device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113681795	GS1

Customer Contacts

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