Healeon HD PRP

GUDID 00850034511405

A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.

Bimini Technologies LLC

Haematological concentrate system

• Primary Device ID: 00850034511405
• NIH Device Record Key: f52e4794-7dc3-436a-84e8-afb570355703
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healeon HD PRP
• Version Model Number: HDPRP30
• Company DUNS: 076649467
• Company Name: Bimini Technologies LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	00850034511405 [Package]; Contains: 00850034511412; Package: Box [3 Units]; In Commercial Distribution
GS1	00850034511412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170136

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [Healeon HD PRP]

• 00850034511405: A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended fo
• 10850034511310: A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended fo