Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system transmitter FDA UDI
- Device Name
- Accessory support device EUDAMEDVyntus CART Mobile FDA UDI
- Model / Reference
- V-859141-13 EUDAMEDFDA UDI
- Description
- Vyntus CART Mobile FDA UDI
Identifiers
- Catalog Number
- V-859141-13 FDA UDI
- Primary DI / UDI-DI
- 34250892903966 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011881QL EUDAMED
- Direct Marketing DI
- 34250892903966 EUDAMED
- 510(k) Number
- K150810 FDA UDI
- FDA Product Code
- BZC FDA UDI
- EMDN Code
- Z12159080 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiography telemetric monitoring system transmitter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1880 FDA UDI
- 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
No
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
Accessory support device by Jaeger Medical GmbH — 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 | 42508929011881QL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jaeger Medical GmbH
- EUDAMED SRN
- DE-MF-000007090
Sources (2)
- EUDAMED a3dfb0bc-2f3a-4def-8ca9-48df097228fd 61 fields · synced Jul 10, 2026
- FDA UDI 6220b1cf-603c-4bce-93be-0ebe587e8999 37 fields · synced May 30, 2026