Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- SentrySuite 3.30 EUDAMEDSentrySuite Software FDA UDI
- Model / Reference
- V-770968 EUDAMED3.30 FDA UDI
- Description
- SentrySuite Software FDA UDI
Identifiers
- Catalog Number
- V-770968 FDA UDI
- Primary DI / UDI-DI
- 04250892905945 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929012112AG3 EUDAMED
- Direct Marketing DI
- 04250892905945 EUDAMED
- 510(k) Number
- K183567 FDA UDI
- FDA Product Code
- BZC FDA UDI
- EMDN Code
- Z12159082 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1880 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
SentrySuite 3.30 by Jaeger Medical GmbH — Class IIa — 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 | 42508929012112AG3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jaeger Medical GmbH
- EUDAMED SRN
- DE-MF-000007090
Sources (2)
- EUDAMED 27bdc46a-9b31-4bb3-a7b8-a6db77aedd99 61 fields · synced Jun 17, 2026
- FDA UDI cfc22217-ee09-4549-a674-b8b92376a0f8 36 fields · synced May 30, 2026