← Back to catalogue

cap-ONE

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden Corp.

Identity

Trade Name
cap-ONE FDA UDI
Generic Name
Carbon dioxide monitor FDA UDI
Device Name
CO2 Sensor Kit for Sleep, CapOne FDA UDI
Model / Reference
TG-921T3 FDA UDI
Description
CO2 Sensor Kit for Sleep, CapOne FDA UDI

Identifiers

Catalog Number
TG-921T3 FDA UDI
Primary DI / UDI-DI
04931921865767 FDA UDI
FDA Product Code
OLV FDA UDI
GWF FDA UDI
CCK FDA UDI
OLT FDA UDI
GMDN Term
Carbon dioxide monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
882.1870 FDA UDI
868.1400 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: Carbon dioxide monitor

cap-ONE by Nihon Kohden Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbon dioxide monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nihon Kohden Corp.

Sources (1)

  • FDA UDI 2f521b60-035e-4a23-b6fa-099943c24c96 35 fields · synced May 31, 2026