Amplifine

GUDID 00850034511887

A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.

Bimini Technologies LLC

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• Primary Device ID: 00850034511887
• NIH Device Record Key: 799ecd62-cd05-4826-8d6d-56a5674dc5ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplifine
• Version Model Number: AMPLIFINE
• 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	00850034511290 [Primary]
GS1	00850034511887 [Package]; Contains: 00850034511290; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK200449

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: 2022-02-17
• Device Publish Date: 2022-02-09

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