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FlowArt®

FDA UDI

Class II (US FDA UDI)

by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi

Identity

Trade Name
FlowArt® FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
Triple Lumen Extension Set FDA UDI
Model / Reference
3010L10 FDA UDI
Description
Triple Lumen Extension Set FDA UDI

Identifiers

Primary DI / UDI-DI
08699443585384 FDA UDI
510(k) Number
K190806 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

Yes

FDA UDI

Category: Intravenous administration tubing extension set

FlowArt® by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Cleared under the same submission

K190806 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi

Sources (1)

  • FDA UDI 25863043-0b24-47d8-8900-ad965eab5d63 36 fields · synced May 30, 2026