CO2 C100

GUDID 00851354004271

The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific treatment or medical purpose.The CO2 Cartridge is a component of the Avinger CO2 Regulator System which also includes a CO2 regulator (regulator), male luer lock connector and a female-female luer lock connector (removable). The Avinger CO2 Regulator System allows for the CO2 cartridge to be replaced once the gas from the engaged CO2 cartridge has been spent. Replacement CO2 Cartridges are shipped in packs of five (5).

AVINGER, INC.

Mechanical atherectomy system, coronary/peripheral

• Primary Device ID: 00851354004271
• NIH Device Record Key: 93d82dea-d1de-472d-8b07-88ca2940a1d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2
• Version Model Number: C100
• Catalog Number: C100
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: 650-241-7030
• Email: tlawson@avinger.com
• Phone: 650-241-7030
• Email: tlawson@avinger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004271 [Primary]

FDA Product Code

• CAN: Regulator, Pressure, Gas Cylinder

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

Devices Manufactured by AVINGER, INC.

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• 00851354004493 - Tigereye: 2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu
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• 00851354004004 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
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• 00851354004042 - Kittykat II: 2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It