ProGen PRP Advantage

GUDID 00850034511535

15ML Platelet Rich Plasma production device.

Bimini Technologies LLC

Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system Haematological concentrate system

• Primary Device ID: 00850034511535
• NIH Device Record Key: f29d426a-fc31-4829-b7b7-4ba2908cc281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGen PRP Advantage
• Version Model Number: PROGEN-A15
• 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	00850034511535 [Package]; Contains: 00850034511566; Package: Box [3 Units]; In Commercial Distribution
GS1	00850034511566 [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: 2022-02-08
• Device Publish Date: 2022-01-31

On-Brand Devices [ProGen PRP Advantage]

• 00850034511559: 30mL Platelet Rich Plasma production device.
• 00850034511535: 15ML Platelet Rich Plasma production device.