← Back to catalogue

Co2

FDA UDI

Class I (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
CO2 FDA UDI
Generic Name
Mechanical atherectomy system, coronary/peripheral FDA UDI
Device Name
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). FDA UDI
Model / Reference
C100 FDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
C100 FDA UDI
Primary DI / UDI-DI
00851354004271 FDA UDI
FDA Product Code
CAN FDA UDI
GMDN Term
Mechanical atherectomy system, coronary/peripheral FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical atherectomy system, coronary/peripheral

Co2 by Avinger, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system, coronary/peripheral.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA UDI 93d82dea-d1de-472d-8b07-88ca2940a1d2 35 fields · synced May 29, 2026