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Oxy2Mask O2/EtCO2

FDA UDI

Class II (US FDA UDI)

by Southmedic Incorporated

Identity

Trade Name
Oxy2Mask O2/EtCO2 FDA UDI
Generic Name
Breathing circuit gas-sampling/monitoring set FDA UDI
Device Name
Oxy2Mask O2/EtCO2 Plus FDA UDI
Model / Reference
OP-2125-14 FDA UDI
Description
Oxy2Mask O2/EtCO2 Plus FDA UDI

Identifiers

Catalog Number
OP-2125-14 FDA UDI
Primary DI / UDI-DI
10620974003219 FDA UDI
510(k) Number
K222511 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

Oxy2Mask O2/EtCO2 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

K222511 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 052b7f8d-d5aa-4cc5-a86c-5e18e0f48398 36 fields · synced May 30, 2026