ProGen PRP Eclipse

GUDID 00850034511221

15ML Platelet Rich Plasma production device.

Bimini Technologies LLC

Haematological concentrate system

• Primary Device ID: 00850034511221
• NIH Device Record Key: 66e69c05-f7c4-4ff3-9598-1a168fbda32d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGen PRP Eclipse
• 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	00850034511214 [Primary]
GS1	00850034511221 [Package]; Contains: 00850034511214; Package: Box [3 Units]; In Commercial Distribution

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: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [ProGen PRP Eclipse]

• 00850034511474: 30mL Platelet Rich Plasma production device.
• 00850034511221: 15ML Platelet Rich Plasma production device.