Identity
- Trade Name
- Co2mmander® ELITE FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- Regulator, Pressure, Gas Cylinder - Co2mmander CO2 Delivery System FDA UDI
- Model / Reference
- COM915-01 or COM915 FDA UDI
- Description
- Regulator, Pressure, Gas Cylinder - Co2mmander CO2 Delivery System FDA UDI
Identifiers
- Catalog Number
- COM915-01 FDA UDI
- Primary DI / UDI-DI
- 00850033705003 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Co2mmander® ELITE by Angioadvancements, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Angioadvancements, Llc
Sources (1)
- FDA UDI d5b78415-63eb-4c3c-bab9-712d04c0d575 35 fields · synced May 30, 2026