ManaMed Inc PF0001-MX

GUDID 00810113682624

The PlasmaFlow 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. This product is made in Mexico.

MANAMED INC

Multi-chamber venous compression system garment, single-use

• Primary Device ID: 00810113682624
• NIH Device Record Key: e8567a9e-9544-495f-a7d5-6c72a8161e6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManaMed Inc
• Version Model Number: PlasmaFlow (Mexico)
• Catalog Number: PF0001-MX
• 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: 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: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net
• Phone: 888-508-0712
• Email: customerservice@manamed.net

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113682624 [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: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [ManaMed Inc]

• 00810113682488: The PrevenTech is intended to be an easy to use sequential compression system, prescribed by a p
• 00810113682549: ManaEZ Ice Wrap Back is a quick fitting, universal, back orthosis. This back brace also includes
• 00810113682532: ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace a
• 00810113682525: A back and thigh extension strap for devices within our ManaEZ Hip line
• 00810113682617: This device is universal, this product does not exist. Cannot delete record
• 00810113682600: ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist brace also includes a
• 00810113682624: The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a p
• 00810113682648: Replacement abduction pillow used to keep shoulder aligned with sling.
• 00810113682631: Replacement abduction pillow with pockets for phone and water bottles used to keep shoulder alig
• 00810113682679: ManaCold Platinum Hip Pad attachment is used to decrease pain, swelling, and muscle spasms after
• 00810113682662: ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms afte
• 00810113682655: ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms aft
• 00810113681092: Reusable extra large size compression calf garment, increases venous blood flow to help prevent