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Accessory Patient gas pathway inspiratory and expiratory
EUDAMEDFDA UDIClass I (EU MDR)
Ref 852828
Identity
- Trade Name
- Jaeger FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Accessory Patient gas pathway inspiratory and expiratory EUDAMEDRebreathing bag 20l FDA UDI
- Model / Reference
- 852828 EUDAMEDFDA UDI
- Description
- Rebreathing bag 20l FDA UDI
Identifiers
- Catalog Number
- 852828 FDA UDI
- Primary DI / UDI-DI
- 34250892907070 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011831Q5 EUDAMED
- 510(k) Number
- K183567 FDA UDI
- FDA Product Code
- BZC FDA UDIDPS FDA UDI
- EMDN Code
- Z12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1880 FDA UDI870.2340 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Accessory Patient gas pathway inspiratory and expiratory by Jaeger Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 42508929011831Q5 | 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 9a8127cf-572f-40c8-a8de-ea9ec79d2373 61 fields · synced Jul 20, 2026
- FDA UDI f6185bb7-eb1d-4889-a57e-538513e4a900 37 fields · synced May 30, 2026