Identity
- Trade Name
- Arterial Extension FDA UDI
- Generic Name
- Intravenous line stopcock FDA UDI
- Device Name
- Arterial Extension 4Ft. PVC Extension Tube with Male Luer Lock and Stopcock FDA UDI
- Model / Reference
- 041104002A FDA UDI
- Description
- Arterial Extension 4Ft. PVC Extension Tube with Male Luer Lock and Stopcock FDA UDI
Identifiers
- Catalog Number
- 041104002A FDA UDI
- Primary DI / UDI-DI
- 00886333201310 FDA UDI
- 510(k) Number
- K780271 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Intravenous line stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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 line stopcock
Arterial Extension by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous line stopcock.
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- VYGON — Vygon Corp. · Class II
- SmartSite — BD Switzerland Sàrl · Class II
Cleared under the same submission
K780271 also covers:
- Arterial Extensions — Argon Medical Devices, Inc.
- Arterial Extensions — Argon Medical Devices, Inc.
- Arterial Extensions 12" PVC Extension Tube — Argon Medical Devices, Inc.
- Five Stopcock Manifold — Argon Medical Devices, Inc.
- Five Stopcock Manifold w/ Male Luer Lock — Argon Medical Devices, Inc.
- Monitoring Kit — Argon Medical Devices, Inc.
- Stopcocks — Argon Medical Devices, Inc.
- Stopcocks — Argon Medical Devices, Inc.
- Three Stopcock Manifold — Argon Medical Devices, Inc.
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
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 8b8fc89c-fb90-41e3-a61b-95fa9b045d61 37 fields · synced Jun 9, 2026