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Single-use kit for adapting 10 mm kit to 12 mm circuits
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NOXKIT-2-12
Identity
- Trade Name
- Single-use kit for adapting 10 mm kit to 12 mm circuits EUDAMEDNOxBOXi FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- NOxBOXi Consumable Kits EUDAMEDSingle-use kit for adapting 10 mm kit to 12 mm circuits EUDAMEDSingle use 12mm size 2 delivery and sampling kit FDA UDI
- Model / Reference
- NOXKIT-2-12 EUDAMEDFDA UDI
- Description
- Single use 12mm size 2 delivery and sampling kit FDA UDI
Identifiers
- Catalog Number
- NXBNOXKIT-2-12 FDA UDI
- Primary DI / UDI-DI
- 05060541640061 EUDAMEDFDA UDI
- Basic UDI-DI
- 506054164NBiKITSMR EUDAMEDB-05060541640061 EUDAMED
- 510(k) Number
- K171696 FDA UDI
- FDA Product Code
- CCL FDA UDIMRQ FDA UDIMRP FDA UDIMRO FDA UDIMRN FDA UDI
- EMDN Code
- Z1203019002,Z1203019085 EUDAMED
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1720 FDA UDI868.2385 FDA UDI868.2380 FDA UDI868.5165 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDIreland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Single-use kit for adapting 10 mm kit to 12 mm circuits by NOxBOX Limited — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506054164NBiKITSMR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506054164NBiKITSMR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NOxBOX Limited
- EUDAMED SRN
- GB-MF-000009734
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 31f93992-6e68-4cdc-ac94-d6a46ccb51d4 61 fields · synced Oct 6, 2026
- EUDAMED 2c6ab589-26fe-426e-b836-8e7602007f76 61 fields · synced May 19, 2026
- FDA UDI b8326933-e3ef-4c83-9cff-cd7a614043aa 37 fields · synced May 30, 2026