Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Gas volume reference standard FDA UDI
- Device Name
- Calibration Syringe EUDAMEDCalibration Syringe 3 Liter FDA UDI
- Model / Reference
- 36-SM2125 EUDAMEDFDA UDI
- Description
- Calibration Syringe 3 Liter FDA UDI
Identifiers
- Catalog Number
- 36-SM2125 FDA UDI
- Primary DI / UDI-DI
- 34250892906134 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929031911QS EUDAMED
- Direct Marketing DI
- 34250892906134 EUDAMED
- FDA Product Code
- BXW FDA UDI
- EMDN Code
- Z12159080 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Gas volume reference standard FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.1870 FDA UDI
- 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Calibration Syringe 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 | 42508929031911QS | 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 0d7035f5-5a7b-4f27-a28d-9fb394c68090 61 fields · synced Jun 18, 2026
- FDA UDI 99a82dac-4af4-4d9c-855e-c46e8fef3a47 35 fields · synced May 30, 2026