Identity
- Trade Name
- VYGON FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- 4CM LEADERFLEX BASIC INSERTION TRAY FDA UDI
- Model / Reference
- VYLF1004 FDA UDI
- Description
- 4CM LEADERFLEX BASIC INSERTION TRAY FDA UDI
Identifiers
- Catalog Number
- VYLF1004 FDA UDI
- Primary DI / UDI-DI
- 00849884004397 FDA UDI
- 510(k) Number
- K141026 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Peripherally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Category: Peripherally-inserted central venous catheter
Vygon by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripherally-inserted central venous catheter.
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Synergy — Health Line International Corp · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- PowerPICC — Bard Access Systems, Inc. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- PowerPICC Provena — Bard Access Systems, Inc. · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
Cleared under the same submission
K141026 also covers:
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
- Vygon Corp.
Sources (1)
- FDA UDI e291becd-91dd-479d-ab97-f61a77617aa4 35 fields · synced Jun 8, 2026