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CMI Health

FDA UDI

Class II (US FDA UDI)

by Cmi Health, Inc.

Identity

Trade Name
CMI Health FDA UDI
Generic Name
Carbon dioxide monitor FDA UDI
Device Name
CMI Health PC-900B Handheld Capnograph and Oximeter FDA UDI
Model / Reference
PC-900B FDA UDI
Description
CMI Health PC-900B Handheld Capnograph and Oximeter FDA UDI

Identifiers

Primary DI / UDI-DI
00850000967007 FDA UDI
510(k) Number
K170820 FDA UDI
FDA Product Code
CCK FDA UDI
DQA FDA UDI
GMDN Term
Carbon dioxide monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 FDA UDI
870.2700 FDA UDI
Commercial Distribution
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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse oximeterCarbon dioxide monitor

CMI Health by Cmi Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbon dioxide monitor.

Cleared under the same submission

K170820 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cmi Health, Inc.

Sources (1)

  • FDA UDI 5a36680e-aec1-4962-a5ac-4287cf8926c9 36 fields · synced May 31, 2026