Identity
- Trade Name
- GaleMed FDA UDI
- Generic Name
- Y-piece breathing circuit connector, reusable FDA UDI
- Device Name
- Neonate Wye Connector 10M w/ Pressure Port FDA UDI
- Model / Reference
- 73023 FDA UDI
- Description
- Neonate Wye Connector 10M w/ Pressure Port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710810083815 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Y-piece breathing circuit connector, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Y-piece breathing circuit connector, reusable.
- STATCUP® II — MICRO DISTRIBUTING, L.C · Class II
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- BE 127-7.5-40 Wye Connector — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- Y-piece straight (A) — Drägerwerk AG & Co. KGaA · Class I
- BE 127 Wye Connector — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed Xiamen Co., Ltd.
Sources (1)
- FDA UDI 3bcdb86c-bdf1-4937-99e4-3b115028c655 34 fields · synced May 30, 2026