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NeoBar® ET Tube Holder - Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref N713Model NeoBar®
Identity
- Trade Name
- NeoBar® ET Tube Holder - Large EUDAMEDNeoBar® FDA UDI
- Generic Name
- Endotracheal tube holder FDA UDI
- Device Name
- NeoBar® EUDAMEDThe NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- NeoBar® EUDAMEDN713 EUDAMEDLarge FDA UDI
- Description
- The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N713 FDA UDI
- Primary DI / UDI-DI
- 10812594011105 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N70900N4 EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Endotracheal tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Market of Registration
- Germany 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
NeoBar® ET Tube Holder - Large by Neotech Products LLC — Class I — 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 | 081259401N70900N4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 754346c1-33de-492a-8b4b-717f043b4382 61 fields · synced Sep 17, 2026
- FDA UDI 9f3b58bd-a1ac-463b-9dcb-0e209edb8985 34 fields · synced May 30, 2026