Identity
- Trade Name
- Neo-Tee EUDAMEDNeo-Tee T-Piece Resuscitator Circuit FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Neo-Tee T-Piece Resuscitator EUDAMED
- Model / Reference
- M1091365VS EUDAMEDFDA UDI
Identifiers
- Catalog Number
- M1091365VS FDA UDI
- Primary DI / UDI-DI
- 10641043913659 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043NEN6 EUDAMED
- 510(k) Number
- K093913 FDA UDI
- FDA Product Code
- BTL FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5925 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
No
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
Neo-Tee by Mercury Medical — 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 | 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 f32447f8-5fc8-4dd6-803b-6368f84ead45 61 fields · synced May 30, 2026
- FDA UDI 7c65d6d2-0052-4582-a767-96f4965bfa3c 35 fields · synced May 30, 2026