Identity
- Trade Name
- SHEATH INTRO LINK KIT 8.5FR L5 MULT=5/50 FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Kits contents: Precutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.53mm x ID 2.74mm x 10cm and Dilator; Guidewire 0.9 x 450mm; Introducers 1.7 x 70mm 1.4 x 70mm; Stopcock; Syringe; Scalpel. FDA UDI
- Model / Reference
- 680132 FDA UDI
- Description
- Kits contents: Precutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.53mm x ID 2.74mm x 10cm and Dilator; Guidewire 0.9 x 450mm; Introducers 1.7 x 70mm 1.4 x 70mm; Stopcock; Syringe; Scalpel. FDA UDI
Identifiers
- Catalog Number
- 680132 FDA UDI
- Primary DI / UDI-DI
- 00886333601325 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 Link Kit 8.5fr L5 Mult=5/50 by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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 6aed9065-f642-45ff-995c-24d512438dc1 36 fields · synced Jun 8, 2026