Identity
- Trade Name
- Double Port CPAP Titration Kit EUDAMEDSensor FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Pro-Tech Accessories EUDAMEDDouble Port CPAP Titration Kit FDA UDI
- Model / Reference
- P1327 EUDAMEDDouble Port CPAP Titration Kit FDA UDI
- Description
- Double Port CPAP Titration Kit FDA UDI
Identifiers
- Catalog Number
- P1327 FDA UDI
- Primary DI / UDI-DI
- 00606959005105 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959005105 EUDAMED
- FDA Product Code
- OLV FDA UDIOLZ FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Double Port CPAP Titration Kit by Respironics, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959005105 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 68ac62f9-a370-49a8-8306-14c9a6f27734 61 fields · synced Jun 20, 2026
- FDA UDI 64262db6-b344-4495-b753-75ad158bc582 36 fields · synced May 29, 2026
- EUDAMED 82ccf3a6-00f1-4248-8895-7c721888ddc7 61 fields · synced Jun 20, 2026