← Back to catalogue
Garbin Plus Ventilator, Bluetooth, INTL
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1040002B
Identity
- Trade Name
- Garbin Plus Ventilator, Bluetooth, INTL EUDAMEDTrilogy 200 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 200 EUDAMEDGarbin Plus Ventilator with BlueTooth, International FDA UDI
- Model / Reference
- 1040002B EUDAMEDGarbin Plus Ventilator, Bluetooth, INTL FDA UDI
- Description
- Garbin Plus Ventilator with BlueTooth, International FDA UDI
Identifiers
- Catalog Number
- 1040002B FDA UDI
- Primary DI / UDI-DI
- 00606959026513 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959026513 EUDAMED
- FDA Product Code
- NOU FDA UDIDQA FDA UDICBK FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb 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
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
Garbin Plus Ventilator, Bluetooth, INTL by Respironics, Inc. — Class IIb — 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-00606959026513 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED bbac460b-6ae2-48d4-9886-3b75b06a3488 61 fields · synced Jun 18, 2026
- FDA UDI 9777253a-d23f-407e-81cd-c8a4461fb1c7 36 fields · synced May 30, 2026