Identity
- Trade Name
- Spacelabs FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Device Name
- CAPNO POD,92516 FDA UDI
- Model / Reference
- Capno Pod FDA UDI
- Description
- CAPNO POD,92516 FDA UDI
Identifiers
- Catalog Number
- 92516 FDA UDI
- Primary DI / UDI-DI
- 10841522113086 FDA UDI
- 510(k) Number
- K121017 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Patient monitoring system module, carbon dioxide 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, carbon dioxide
Spacelabs by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient monitoring system module, carbon dioxide.
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Cleared under the same submission
K121017 also covers:
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
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 61fb0964-3639-4797-92d3-d92bb55f109d 36 fields · synced May 30, 2026