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Dosi-Flow

FDA UDI

Class II (US FDA UDI)

by Leventon Sau

Identity

Trade Name
DOSI-FLOW FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
I.V. Flow Regulator with Adult Set (20drops/ml) and Needle Free Injection Site FDA UDI
Model / Reference
L259000097 FDA UDI
Description
I.V. Flow Regulator with Adult Set (20drops/ml) and Needle Free Injection Site FDA UDI

Identifiers

Primary DI / UDI-DI
08436020760563 FDA UDI
510(k) Number
K952810 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
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

Yes

FDA UDI

Category: Basic intravenous administration set, noninvasive

Dosi-Flow by Leventon Sau — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

Cleared under the same submission

K952810 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leventon Sau

Sources (1)

  • FDA UDI 43dee9b4-b5d2-412f-b153-7d2168dec135 35 fields · synced Jun 8, 2026