Identity
- Trade Name
- Nfuze FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Model / Reference
- EJN004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 26972620118848 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
- 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
Category: Intravenous administration tubing extension set
Nfuze by Bq Plus Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
K223645 also covers:
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — BQ PLUS MEDICAL CO., LTD.
- Nfuze — 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 b9ecfad4-cdbf-48f9-b54c-4748b941bb7e 33 fields · synced May 30, 2026