Hands Free Syringe 412073-001

GUDID 00850316008012

Hands Free Syringe single-use sterile syringe

BLUEFIN MEDICAL LLC

Pain management medication delivery system

• Primary Device ID: 00850316008012
• NIH Device Record Key: 735b6eba-8f61-421a-8e6d-b1ebe665565e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hands Free Syringe
• Version Model Number: HFS-SYR
• Catalog Number: 412073-001
• Company DUNS: 080812392
• Company Name: BLUEFIN MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850316008005 [Primary]
GS1	00850316008012 [Package]; Contains: 00850316008005; Package: BOX [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153599

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-17

On-Brand Devices [Hands Free Syringe]

• 00850316008036: Hands Free Syringe reusable foot pedal, 1 unit per box
• 00850316008029: Hands Free Syringe limited reuse motor housing, 1 unit per box
• 00850316008012: Hands Free Syringe single-use sterile syringe