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Swivel Oxygen Nipple Connector
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PO-85120 Model PO-85120
Identity
- Trade Name
- Swivel Oxygen Nipple Connector EUDAMEDNUT/NIPPLE,OX,TAPER,SWIVEL 50/BG 500/CA FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Swivel Oxygen Nipple Connector EUDAMEDNUT/NIPPLE,OX,TAPER,SWIVEL 50/BG 500/CA FDA UDI
- Model / Reference
- PO-85120 EUDAMEDFDA UDI
- Description
- NUT/NIPPLE,OX,TAPER,SWIVEL 50/BG 500/CA FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-PO-851206T EUDAMED04716770851204 FDA UDI
- Basic UDI-DI
- B-PO-851206T EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- R03010204 OXYGEN ADMINISTRATION TUBINGS 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
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Oxygen administration tubing
Swivel Oxygen Nipple Connector by Besmed Health Business Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Oxygen administration tubing.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-PO-851206T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED 950fdeb7-9a88-4187-be99-2b3d313396d3 61 fields · synced Jul 16, 2026
- FDA UDI 7fd0dafb-47ce-46a4-aca0-90c1aa4fbfa8 33 fields · synced May 30, 2026