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Capnoxygen®

FDA UDI

Class II (US FDA UDI)

by Southmedic Incorporated

Identity

Trade Name
Capnoxygen® FDA UDI
Generic Name
Breathing circuit gas-sampling/monitoring set FDA UDI
Device Name
Capnoxygen Mask (Adult) FDA UDI
Model / Reference
CO2-01 FDA UDI
Description
Capnoxygen Mask (Adult) FDA UDI

Identifiers

Catalog Number
CO2-01 FDA UDI
Primary DI / UDI-DI
10620974001048 FDA UDI
510(k) Number
K971229 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Breathing circuit gas-sampling/monitoring set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing circuit gas-sampling/monitoring set

Capnoxygen® by Southmedic Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing circuit gas-sampling/monitoring set.

Cleared under the same submission

K971229 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Southmedic Incorporated

Sources (1)

  • FDA UDI cef8e281-1208-4e32-a764-f0e13bac83e5 37 fields · synced May 31, 2026