Identity
- Trade Name
- Trilogy In-Use Bag EUDAMEDTrilogy FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy Family Ventilator Accessories EUDAMEDTrilogy Ventilator In-Use Device Bag FDA UDI
- Model / Reference
- 1040420 EUDAMEDTrilogy In-Use Bag FDA UDI
- Description
- Trilogy Ventilator In-Use Device Bag FDA UDI
Identifiers
- Catalog Number
- 1040420 FDA UDI
- Primary DI / UDI-DI
- 00606959043145 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM119LW EUDAMED
- Direct Marketing DI
- 00606959043145 EUDAMED
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203019080,Z1203019099 EUDAMED
- GMDN Term
- Portable electric ventilator 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
Trilogy In-Use Bag 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 | 0606959BM119LW | 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 0c586d12-f0a8-460f-a3f0-dd34d1557bc2 61 fields · synced Jun 18, 2026
- FDA UDI 1af8d2fc-dfba-47a8-99e7-9141fb8bf48e 35 fields · synced May 30, 2026