Identity
- Trade Name
- SHEATH INTRO POP KIT 9FR L5 MULT=5/50 FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.70mm x ID 2.90mmx 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.4x70mm, stopcock FDA UDI
- Model / Reference
- 680156 FDA UDI
- Description
- Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.70mm x ID 2.90mmx 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.4x70mm, stopcock FDA UDI
Identifiers
- Catalog Number
- 680156 FDA UDI
- Primary DI / UDI-DI
- 00886333601561 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 Pop Kit 9fr L5 Mult=5/50 by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Haemostasis valve.
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- VSI Micro-HV Introducer Kit — Galt Medical Corp. · Class II
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- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Honor® — Merit Medical Systems, Inc. · Class II
- AVANTI — Cordis Corp. · 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 |
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Manufacturer
- Manufacturer
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI dfb2a28b-f773-4f85-8e00-f5c7ba52f73d 36 fields · synced May 29, 2026