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Co2mmander® ELITE

FDA UDI

Class I (US FDA UDI)

by Angioadvancements, Llc

Identity

Trade Name
Co2mmander® ELITE FDA UDI
Generic Name
Non-fixed medical gas cylinder regulator FDA UDI
Device Name
Co2mmander® ELITE FDA UDI
Model / Reference
COM915 FDA UDI
Description
Co2mmander® ELITE FDA UDI

Identifiers

Catalog Number
COM915 FDA UDI
Primary DI / UDI-DI
00850033705072 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
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Non-fixed medical gas cylinder regulator

Co2mmander® ELITE by Angioadvancements, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-fixed medical gas cylinder regulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angioadvancements, Llc

Sources (1)

  • FDA UDI ac8e1f51-8658-4337-b421-77fb3d6c4551 34 fields · synced Jun 8, 2026