Identity
- Trade Name
- VYGON FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- 3FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY FDA UDI
- Model / Reference
- VYML3S1001 FDA UDI
- Description
- 3FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY FDA UDI
Identifiers
- Catalog Number
- VYML3S1001 FDA UDI
- Primary DI / UDI-DI
- 08498840012550 FDA UDI
- 510(k) Number
- K181208 FDA UDI
- FDA Product Code
- PND FDA UDI
- GMDN Term
- Peripheral vascular 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
No
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: Peripheral vascular catheter
Vygon by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular catheter.
- Arterial Line Kit — Argon Medical Devices, Inc. · Class I
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- POWERWAND — ICU MEDICAL, INC. · Class II
- POWERWAND — Access Scientific, Inc. · Class II
Cleared under the same submission
K181208 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 ea47bf7b-30a9-42d2-9221-d3eedfd4f606 35 fields · synced May 30, 2026