PlasmaFlow X XPF0001

GUDID 00850998008478

The PlasmaFlow X is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

Manamed, Inc.

Intermittent venous compression system

• Primary Device ID: 00850998008478
• NIH Device Record Key: 69515c98-e83c-4250-abc4-8f2601236e0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlasmaFlow X
• Version Model Number: XPF0001
• Catalog Number: XPF0001
• Company DUNS: 084042331
• Company Name: Manamed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com
• Phone: 8885080712
• Email: support@manamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850998008478 [Primary]

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: 2025-02-28
• Device Publish Date: 2025-02-20

Devices Manufactured by Manamed, Inc.

• 00850998008478 - PlasmaFlow X: 2025-02-28The PlasmaFlow X is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
• 00850998008478 - PlasmaFlow X: 2025-02-28 The PlasmaFlow X is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home
• 00810113688473 - ManaMed Inc: 2024-07-11 This Ultrasound Coupling Gel is to be used with our ManaSport+ product or any other Ultrasound devices or non-adhesive electrode
• 00850998008331 - ManaMed Inc: 2024-07-11 Reusable universal compression foot garment, increases venous blood flow to help prevent deep vein thrombosis.
• 00850998008348 - ManaMed Inc: 2024-07-11 Reusable universal compression thigh, knee, and upper calf garment; increases venous blood flow to help prevent deep vein thromb