Identity
- Trade Name
- SHEATH INTRO KIT 6FR L5 MULT=5/50 FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD 2.76mm x ID 1.90mm x 10cm and Dilator, guidewire 0.9x450mm, introducers 1.7x70mm 1.4x70mm, contamination shield, stopcock, syringe and scalpel. FDA UDI
- Model / Reference
- 680128 FDA UDI
- Description
- Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD 2.76mm x ID 1.90mm x 10cm and Dilator, guidewire 0.9x450mm, introducers 1.7x70mm 1.4x70mm, contamination shield, stopcock, syringe and scalpel. FDA UDI
Identifiers
- Catalog Number
- 680128 FDA UDI
- Primary DI / UDI-DI
- 00886333601288 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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: Haemostasis valve
Sheath Intro Kit 6fr L5 Mult=5/50 by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemostasis valve.
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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 Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 467719b5-59dd-4f66-bfaf-18ef91f8647b 36 fields · synced May 30, 2026