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Nfuze

FDA UDI

Class II (US FDA UDI)

by Bq Plus Medical Co., Ltd.

Identity

Trade Name
Nfuze FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Model / Reference
PRS401 FDA UDI

Identifiers

Primary DI / UDI-DI
06972620112910 FDA UDI
510(k) Number
K210381 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive 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
MRI Safety
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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bq Plus Medical Co., Ltd.

Sources (1)

  • FDA UDI 90599d21-264d-4dcf-a39d-c6b1f736638f 34 fields · synced May 30, 2026