Identity
- Trade Name
- FlowArt® FDA UDI
- Generic Name
- Negative-pressure intravenous line needleless valve-connector FDA UDI
- Device Name
- Three Port Flexible Manifold w/One-way Split Septum Needle-Free Valves FDA UDI
- Model / Reference
- AYWB4010TY FDA UDI
- Description
- Three Port Flexible Manifold w/One-way Split Septum Needle-Free Valves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08699443580075 FDA UDI
- 510(k) Number
- K190806 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Negative-pressure intravenous line needleless valve-connector 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: Negative-pressure intravenous line needleless valve-connector
FlowArt® by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 8dc1f4e7-fcb0-4e59-9500-4c25bb34d336 36 fields · synced May 30, 2026