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Seattle PAP plus
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MP02260Model 308041XK19Z000
Identity
- Trade Name
- Seattle PAP plus EUDAMEDFDA UDI
- Generic Name
- In-line CPAP set, non-nebulizing FDA UDI
- Model / Reference
- MP02260 EUDAMEDFDA UDI308041XK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675548904 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751308041XK19Z000F6 EUDAMED
- FDA Product Code
- OGG FDA UDI
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
- GMDN Term
- In-line CPAP set, non-nebulizing FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: In-line CPAP set, non-nebulizing
Seattle PAP plus 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 8ed91fd6-66e9-4a96-92ee-197f2276ea54 32 fields · synced Jun 19, 2026
- EUDAMED 6ec37258-d159-4b14-a87d-4fc87790cab3 61 fields · synced Jun 19, 2026