Identity
- Trade Name
- FlowArt® FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- Double Lumen Extension Set FDA UDI
- Model / Reference
- 2010L10 FDA UDI
- Description
- Double Lumen Extension Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08699443585377 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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous administration tubing extension set.
- VYGON — Vygon Corp. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- BD MaxPlus — BD Switzerland Sàrl · Class II
- Statlock IV Select Start Kit — Bard Access Systems, Inc. · Class II
- Statlock IV — Bard Access Systems, Inc. · Class II
Cleared under the same submission
K190806 also covers:
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
- FlowArt® — ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI f880156e-4155-4db2-99ef-03df0fcc0435 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026