PlasmaFlow PF0001

GUDID B402PF00011E

The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to

MANAMED INC

Multi-chamber venous compression system garment, single-use

• Primary Device ID: B402PF00011E
• NIH Device Record Key: 02750352-c4b6-4224-b8a4-5aa3d032de9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlasmaFlow
• Version Model Number: ManaMed
• Catalog Number: PF0001
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B402PF00011E [Primary]

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-12

On-Brand Devices [PlasmaFlow]

• 00850998008003: The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a p
• B402PF00011E: The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a