Identity
- Trade Name
- zRIP DuraBelt Kit, Ped., QDC EUDAMEDzRIP DuraBelt FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- ProTech Respiratory Effort Sensors EUDAMEDzRIP Durabelt Kit, Pediatric, QDC FDA UDI
- Model / Reference
- 1075967 EUDAMEDZRIP DURABELT FDA UDI
- Description
- zRIP Durabelt Kit, Pediatric, QDC FDA UDI
Identifiers
- Catalog Number
- 1075967 FDA UDI
- Primary DI / UDI-DI
- 00606959010499 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959010499 EUDAMED
- 510(k) Number
- K013905 FDA UDI
- FDA Product Code
- MNR 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
- 868.2375 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
zRIP DuraBelt Kit, Ped., QDC 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-00606959010499 | 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 (2)
- EUDAMED 244e8648-6625-466f-8ba4-ec6d8c6dcafb 61 fields · synced Jun 18, 2026
- FDA UDI e9f27b4f-23a1-4cfc-84a5-908732fceaf6 37 fields · synced May 30, 2026