Identity
- Trade Name
- Capnostream20p FDA UDI
- Generic Name
- Carbon dioxide monitor FDA UDI
- Device Name
- Portable Bedside Capnography Demo Loaner FDA UDI
- Model / Reference
- DLCS08652-03 FDA UDI
- Description
- Portable Bedside Capnography Demo Loaner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521771703 FDA UDI
- 510(k) Number
- K123690 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Carbon dioxide monitor 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
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
Capnostream20p by Oridion Medical 1987 Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide monitor.
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- cap-ONE — Nihon Kohden Corp. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class II
- cap-ONE — NIHON KOHDEN AMERICA, INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class I
- Nonin — Nonin Medical, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Oridion Medical 1987 Ltd.
Sources (1)
- FDA UDI c8c99891-3e45-46f0-aea7-69fdc5c212b0 36 fields · synced May 30, 2026