GENESIS PRP 15mL Concentrating System

GUDID 00850034511498

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: 00850034511498
• NIH Device Record Key: 3417a37e-ab24-4806-bf27-66b362a8d711
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESIS PRP 15mL Concentrating System
• Version Model Number: HEALPRP15
• 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	00850034511498 [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

Devices Manufactured by Bimini Technologies LLC

• 00850034511993 - DIRECT2 Lid: 2024-10-14 This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The DIRECT2 connects an
• 00850034511009 - Puregraft 850 System Twin Pack: 2024-08-30 A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filteri
• 00850034511153 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511337 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511399 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511627 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511658 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511672 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant