PlasmaFlight

GUDID 00850998008294

The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

MANAMED INC

Sequential venous compression system

• Primary Device ID: 00850998008294
• NIH Device Record Key: 6ce6e0fe-bb8a-4458-b254-2f97f4e3778e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlasmaFlight
• Version Model Number: FLIGHT001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850998008294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200351

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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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