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RJ9 to 1/4" Nurse Call Cable Alarm - Open
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1080248
Identity
- Trade Name
- RJ9 to 1/4" Nurse Call Cable Alarm - Open EUDAMEDNurse call FDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- Trilogy Evo Family Class I EUDAMEDRJ9 to 1/4" Nurse Call Cable Alarm - Open FDA UDI
- Model / Reference
- 1080248 EUDAMEDRJ9 to 1/4" Nurse Call Cable Alarm - Open FDA UDI
- Description
- RJ9 to 1/4" Nurse Call Cable Alarm - Open FDA UDI
Identifiers
- Catalog Number
- 1080248 FDA UDI
- Primary DI / UDI-DI
- 00606959043183 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM126LT EUDAMED
- Direct Marketing DI
- 00606959043183 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203019080,Z1203019099 EUDAMED
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
RJ9 to 1/4" Nurse Call Cable Alarm - Open by Respironics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0606959BM126LT | 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
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED dc3b51aa-26f4-4101-86fc-7b390686d770 61 fields · synced Jul 15, 2026
- FDA UDI cce3a414-42eb-4a88-b56a-3aeeb0dedb71 36 fields · synced May 30, 2026