← Back to catalogue

Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
VYGON FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
PROCEDURE KIT FDA UDI
Model / Reference
AMS-9140A FDA UDI
Description
PROCEDURE KIT FDA UDI

Identifiers

Catalog Number
AMS-9140A FDA UDI
Primary DI / UDI-DI
00849884003406 FDA UDI
FDA Product Code
OWL FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable 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

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: Vascular catheter introduction set, nonimplantable

VYGON is a high-quality, single-use peripheral catheter insertion kit designed for use in medical procedures. With its openFDA-compliant design and durable construction, this device ensures safe and effective insertion of vascular access devices into the body. VYGON is not labeled as MRI Safe or No Radiation Exposure, and it does not contain essential information necessary for safe use.

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vygon Corp.

Sources (1)

  • FDA UDI b25e3aad-0541-4e23-b870-7a9a65174199 34 fields · synced Jul 22, 2026