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RAM Cannula® - Nasal Oxygen Cannula - Infant
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref N4903Model RAM Cannula®
Identity
- Trade Name
- RAM Cannula® - Nasal Oxygen Cannula - Infant EUDAMEDNeotech RAM Cannula® FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- RAM Cannula® EUDAMED"The Neotech RAM Cannula is intended to be used for preterm and term neonates, infants, and pediatric patients who require supplemental oxygen, respiratory support or assistance in breathing in an ambulatory, hospital or institutional environment. It is used to provide oxygen with the following methods: 1. Heated or unheated, humidified low flow oxygen. 2. Heated, humidified high flow oxygen." FDA UDI
- Model / Reference
- RAM Cannula® EUDAMEDN4903 EUDAMEDOrange - Infant FDA UDI
- Description
- "The Neotech RAM Cannula is intended to be used for preterm and term neonates, infants, and pediatric patients who require supplemental oxygen, respiratory support or assistance in breathing in an ambulatory, hospital or institutional environment. It is used to provide oxygen with the following methods: 1. Heated or unheated, humidified low flow oxygen. 2. Heated, humidified high flow oxygen." FDA UDI
Identifiers
- Catalog Number
- N4903 FDA UDI
- Primary DI / UDI-DI
- 10812594011310 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N49000MM EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- R0301020302 HIGH FLOW THERAPY NASAL CANNULAS (HFNC) EUDAMED
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 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
RAM Cannula® - Nasal Oxygen Cannula - Infant by Neotech Products LLC — 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 | 081259401N49000MM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 66b67cdb-a019-44aa-9a47-25db1f52fd7a 61 fields · synced Jun 19, 2026
- FDA UDI 464509fe-4230-43a2-9fda-54d64fa79506 34 fields · synced May 30, 2026