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Trilogy 100 Ventilator, INTL — Bluetooth
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1054096BModel Trilogy 100, Garbin
Identity
- Trade Name
- Trilogy 100 Ventilator, INTL — Bluetooth EUDAMEDTrilogy 100 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 100 Ventilator with Bluetooth, International FDA UDI
- Model / Reference
- Trilogy 100, Garbin EUDAMED1054096B EUDAMEDTrilogy100 Ventilator, Bluetooth, International FDA UDI
- Description
- Trilogy 100 Ventilator with Bluetooth, International FDA UDI
Identifiers
- Catalog Number
- 1054096B FDA UDI
- Primary DI / UDI-DI
- 00606959026469 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959026469 EUDAMED
- FDA Product Code
- CBK FDA UDINOU FDA UDIDQA FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI870.2700 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Trilogy 100 Ventilator, INTL — Bluetooth by Respironics, Inc. — Class IIa — 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-00606959026469 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 ea59cf97-baf5-4ed3-a3f4-8994e025762c 61 fields · synced Jun 20, 2026
- FDA UDI 8160fcb2-c2ff-45a3-8b2b-fe83369e7050 36 fields · synced May 30, 2026
- EUDAMED 16d4d1ad-cf22-4cba-b0e1-79378ff5cbc8 61 fields · synced Jun 20, 2026