Home GUDID 00850998008898 ManaFlow 52
Primary DI 00850998008898
Brand ManaFlow 52
Company Manamed, Inc.
Model MFLOW52
Catalog number MFLOW52
Device description The ManaFlow system, part number MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. The ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: • Treatment of lymphedema • Treatment of chronic venous insufficiency • Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers • Reducing venous leg ulcer healing time • Reducing edema due to venous stasis • Enhancing venous return The device is intended for home, and hospital use.
Published 2022-06-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name JOW Sleeve, Limb, Compressible
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JOW Sleeve, Limb, Compressible Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850998008898 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850998008898 00850998008898 850998008898 0850998008898
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 084042331 Device count 1 Lot or batch true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810113682730 ManaSlide MSLIDE MSLIDE01 2025-11-25 00810113688473 ManaMed Inc ManaMed Ultrasound Coupling Gel MANAGEL01 2022-12-31 00810113684154 ManaEZ Wrist Left, Extra Large EZW3908L-XL EZW3908L-XL 2025-10-17 00810113684161 ManaEZ Wrist Left, Extra Small EZW3908L-XS EZW3908L-XS 2025-10-17 00810113684178 ManaEZ Wrist Right, Extra Large EZW3908R-XL EZW3908R-XL 2025-10-17 00810113684185 ManaEZ Wrist Right, Extra Small EZW3908R-XS EZW3908R-XS 2025-10-17 00810113682969 "ManaEZ Single Panel Knee Immobilizer 18""" EZIMM01-18 EZIMM01-18 2025-11-25 00810113682976 "ManaEZ Single Panel Knee Immobilizer 20""" EZIMM01-20 EZIMM01-20 2025-11-25 00810113682983 "ManaEZ Single Panel Knee Immobilizer 24""" EZIMM01-24 EZIMM01-24 2025-11-25 00810113682990 "ManaEZ 3 Panel Knee Immobilizer 18""" EZ3PIMM01-18 EZ3PIMM01-18 2025-11-25 00810113683003 "ManaEZ 3 Panel Knee Immobilizer 20""" EZ3PIMM01-20 EZ3PIMM01-20 2025-11-25 00810113683010 "ManaEZ 3 Panel Knee Immobilizer 24""" EZ3PIMM01-24 EZ3PIMM01-24 2025-11-25 00810113683294 "ManaEZ 3 Panel Knee Immobilizer 16""" EZ3PIMM01-16 EZ3PIMM01-16 2025-11-25 00810113682600 ManaMed Inc ManaEZ Ice Wrist EZIWST01 2022-10-13 00850998008119 ManaMed ManaEZ Wrist Universal Right EZW3908R 2022-06-20 00850998008126 ManaMed ManaEZ Wrist Universal Left EZW3908L 2022-06-20 00810113683065 ManaEZ ROM Ice Short EZR001-XSM EZR001-XSM 2025-10-17 00810113683515 ManaEZ Hip Ice CureTech EZHIP01B-CT EZHIP01B-CT 2025-10-03 00810113683522 ManaEZ ROM Ice CureTech EZR001-CT EZR001-CT 2025-10-03 00810113683539 ManaEZ Shoulder Ice CureTech EZSHLD-CT EZSHLD-CT 2025-10-03
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