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nCPAP Prong, #4 w/ Pressure Port Elbow
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AN0014Model (G) Bubble CPAP System
Identity
- Trade Name
- nCPAP Prong, #4 w/ Pressure Port Elbow EUDAMEDBabi.Plus FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- nCannula Kit EUDAMED
- Model / Reference
- (G) Bubble CPAP System EUDAMEDAN0014 EUDAMEDB024 FDA UDI
Identifiers
- Catalog Number
- nCPAP Nasal Prong Size 4 FDA UDI
- Primary DI / UDI-DI
- 04710810119743 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNGN95 EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- R02010401 CPAP CIRCUITS EUDAMED
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
nCPAP Prong, #4 w/ Pressure Port Elbow by GaleMed Corporation — Class IIa — 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 | 471081008NNGN95 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8a06a18c-fe7c-4dad-b5a8-c3496ec00796 61 fields · synced Jul 31, 2026
- FDA UDI 36e6be1f-0aa2-4481-b841-74224055c6d9 33 fields · synced May 30, 2026