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Exp-Valve disp RFID
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MP01060Model 308004XK19Z000
Identity
- Trade Name
- Exsp.-Ventil Einweg RFID EUDAMEDExp-Valve disp RFID FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Model / Reference
- MP01060 EUDAMEDFDA UDI308004XK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675421627 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751308004XK19Z000DP EUDAMED
- 510(k) Number
- K093633 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203010585 PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES EUDAMED
- GMDN Term
- Non-rebreathing valve, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-rebreathing valve, single-use
Exp-Valve disp RFID by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI c79e3368-b703-4afb-b36a-fc7312f899f1 33 fields · synced Jul 15, 2026
- EUDAMED e5edce48-c5b2-4216-b94a-5a677fda939c 61 fields · synced Jul 15, 2026