Identity
- Trade Name
- STOPCOCK HP OFF-DIR(4W-L) FDA UDI
- Generic Name
- Intravenous line stopcock FDA UDI
- Device Name
- Single pack High Pressure OFF 4-Way stopcock FDA UDI
- Model / Reference
- 682049 FDA UDI
- Description
- Single pack High Pressure OFF 4-Way stopcock FDA UDI
Identifiers
- Catalog Number
- 682049 FDA UDI
- Primary DI / UDI-DI
- 00886333620494 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Intravenous line stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
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
No
FDA UDI
Category: Intravenous line stopcock
Stopcock Hp Off-Dir(4w-L) by Argon Critical Care Systems Singapore Pte. Ltd. — 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
- Kabi Access Infusion Sets — CODAN US Corporation · 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
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 00923a97-83a8-4038-9451-672d3f1a8aa8 35 fields · synced May 30, 2026