Identity
- Trade Name
- Neo-Tee EUDAMEDNeo-Tee Connector Adapter FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Device Name
- Neo-Tee T-Piece Resuscitator EUDAMED
- Model / Reference
- 10-55321 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 10-55321 FDA UDI
- Primary DI / UDI-DI
- 10641043553213 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043NEN6 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Straight/elbow breathing circuit connector, single-use 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
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
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Straight/elbow breathing circuit connector, reusable
Neo-Tee by Mercury Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0641043NEN6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a849a15f-3b1e-4c51-9697-954e6dea1a21 61 fields · synced Oct 6, 2026
- FDA UDI bdd18b53-2fd0-4f5d-9382-074f81275264 34 fields · synced May 30, 2026