Identity
- Trade Name
- Y Connector, 15F, 15Mx2, 4.3F, PC EUDAMEDGaleMed FDA UDI
- Generic Name
- Y-piece breathing circuit connector, reusable FDA UDI
- Device Name
- Reusable Y Connector EUDAMEDChild Wye Connector 15M w/Pressure Port FDA UDI
- Model / Reference
- (P) Connector EUDAMEDAC0035 EUDAMED73038 FDA UDI
- Description
- Child Wye Connector 15M w/Pressure Port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710810085208 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008RNP398 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Y-piece breathing circuit connector, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 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
Yes
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
No
FDA UDI
Category: Y-piece breathing circuit connector, reusable
GaleMed by GaleMed Xiamen Co., Ltd. — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Xiamen Co., Ltd.
Sources (2)
- FDA UDI c01310b5-5570-4393-827e-2cfa0d025c24 34 fields · synced Jun 18, 2026
- EUDAMED 820444a6-c9bb-4696-82af-dc57d9bfa893 61 fields · synced Jun 18, 2026