Identity
- Trade Name
- Nfuze FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Model / Reference
- BNS103 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972620112986 FDA UDI
- 510(k) Number
- K210381 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
MR Safe FDA UDI
Nfuze by Bq Plus Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K210381 also covers:
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- BQ+ — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
- IMED — BQ PLUS MEDICAL CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bq Plus Medical Co., Ltd.
Sources (1)
- FDA UDI 8b5ed3cb-66de-4af1-8fe4-bea106d05b86 34 fields · synced May 30, 2026