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LifeVent200 Ventilator, Sapio, Bluetooth
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SP1032800B
Identity
- Trade Name
- LifeVent200 Ventilator, Sapio, Bluetooth EUDAMEDTrilogy 200 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 200 EUDAMEDLifeVent200 Ventilator, Sapio, Bluetooth FDA UDI
- Model / Reference
- SP1032800B EUDAMEDLifeVent200 Ventilator, Sapio, Bluetooth FDA UDI
- Description
- LifeVent200 Ventilator, Sapio, Bluetooth FDA UDI
Identifiers
- Catalog Number
- SP1032800B FDA UDI
- Primary DI / UDI-DI
- 00606959050099 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959050099 EUDAMED
- 510(k) Number
- K093416 FDA UDI
- FDA Product Code
- DQA 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
- 870.2700 FDA UDI868.5895 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
LifeVent200 Ventilator, Sapio, Bluetooth 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-00606959050099 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 c8565fa3-e2e6-4dcf-b879-793c3cbe287e 61 fields · synced Jun 19, 2026
- FDA UDI db8c5b9a-1248-4706-83c9-96377ec340d8 37 fields · synced May 25, 2026
- EUDAMED be358f6f-c45e-49c7-99b3-4119ad5cb872 61 fields · synced Jun 14, 2026