Hands Free Syringe 411987-001

GUDID 00814384020383

Pouch of 1 sterile 20 mL syringe, stored inside a box of 20

CONCERT MEDICAL, LLC

Pain management medication delivery system

• Primary Device ID: 00814384020383
• NIH Device Record Key: ebef4888-2c3d-4642-a57f-413cf8f48483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hands Free Syringe
• Version Model Number: HFS-SYR
• Catalog Number: 411987-001
• Company DUNS: 189689800
• Company Name: CONCERT 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814384020383 [Primary]
GS1	00814384020390 [Package]; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-06

On-Brand Devices [Hands Free Syringe]

• 00814384020413: 1 Motor Housing unit that injects/aspirates the HFS Sterile Syringe
• 00814384020406: 1 Foot pedal unit that controls injection/aspiration of HFS Sterile Syringe.
• 00814384020383: Pouch of 1 sterile 20 mL syringe, stored inside a box of 20