Identity
- Trade Name
- Kabi Access Infusion Sets FDA UDI
- Generic Name
- Intravenous line stopcock FDA UDI
- Device Name
- Manifold 2 Port 4-way stopcocks and rotating male Luer-lock FDA UDI
- Model / Reference
- FK70110K FDA UDI
- Description
- Manifold 2 Port 4-way stopcocks and rotating male Luer-lock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10813153028008 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Intravenous line stopcock 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
No
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
Kabi Access Infusion Sets by CODAN US Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous line stopcock.
- Stopcocks — Argon Medical Devices, Inc. · Class II
- Medex — ICU MEDICAL, INC. · Class II
- SPC-4(4-WAY STOPCOCK) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class II
- SmartSite — BD Switzerland Sàrl · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CODAN US Corporation
Sources (1)
- FDA UDI 31577e8e-514a-426a-91ca-7d0f4dfe7692 33 fields · synced Jun 6, 2026