ManaFlow52 MFLOW2

GUDID 00850998008287

Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure

MANAMED INC

Sequential venous compression system

• Primary Device ID: 00850998008287
• NIH Device Record Key: 2467b91d-c938-4caf-ae21-268ba1484140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManaFlow52
• Version Model Number: MFLOW52
• Catalog Number: MFLOW2
• Company DUNS: 084042331
• Company Name: MANAMED INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850998008287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200353

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

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• 00850998008904 - ManaMed: 2024-05-08 The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or aid in the prevention of DVT. T
• 00810113682655 - ManaMed Inc: 2023-09-05 ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold t
• 00810113682662 - ManaMed Inc: 2023-09-05 ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold th