Identity
- Trade Name
- Spacelabs Healthcare FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- CAPNO MODULE, 92517, REFURB FDA UDI
- Model / Reference
- Capno Module FDA UDI
- Description
- CAPNO MODULE, 92517, REFURB FDA UDI
Identifiers
- Catalog Number
- R-92517 FDA UDI
- Primary DI / UDI-DI
- 10841522108839 FDA UDI
- 510(k) Number
- K130112 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, reusable 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
Yes
FDA UDI
Category: Anaesthesia breathing circuit, reusable
Spacelabs Healthcare by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, reusable.
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
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- Sil.Plus — Galemed Corp. · Class I
- PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit — Global Life Sciences Solutions USA LLC · Class II
Cleared under the same submission
K130112 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 f1cf5f64-efef-4896-b0b2-937f482cd44c 36 fields · synced Jun 6, 2026