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FlowArt®

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref AF6112Model Filter sets

by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi

Identity

Trade Name
FlowArt EUDAMED
FlowArt® FDA UDI
Generic Name
Intravenous line filter FDA UDI
Device Name
Single Set with 1.2 micron Filter EUDAMED
Single Set with 1.2 micron Filter Set FDA UDI
Model / Reference
AF6112 EUDAMEDFDA UDI
Filter sets EUDAMED
Description
Single Set with 1.2 micron Filter Set FDA UDI

Identifiers

Primary DI / UDI-DI
08699443583519 EUDAMEDFDA UDI
Basic UDI-DI
B-08699443583519 EUDAMED
510(k) Number
K190806 FDA UDI
FDA Product Code
FPA FDA UDI
EMDN Code
A04010101 WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS) EUDAMED
GMDN Term
Intravenous line filter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Market of Registration
Türkiye EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

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

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 (2)

  • FDA UDI e9c64fc9-a3f7-438b-ba59-ce8c982acbb5 36 fields · synced Oct 7, 2026
  • EUDAMED 0d3cb7b7-b8bb-455c-a6b7-1e07cf3c984a 61 fields · synced Jul 9, 2026