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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
PEDIATRIC PICC INSERTION KIT FDA UDI
Model / Reference
AMS-8034CP FDA UDI
Description
PEDIATRIC PICC INSERTION KIT FDA UDI

Identifiers

Catalog Number
AMS-8034CP FDA UDI
Primary DI / UDI-DI
00849884003482 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 by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vygon Corp.

Sources (1)

  • FDA UDI f7fb7543-b6be-46b2-ac24-05b3fe83d171 34 fields · synced May 30, 2026