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Mci

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
MCI FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
MAXIMUM BARRIER TRAY FDA UDI
Model / Reference
MCITX-1 FDA UDI
Description
MAXIMUM BARRIER TRAY FDA UDI

Identifiers

Catalog Number
MCITX-1 FDA UDI
Primary DI / UDI-DI
08498840009604 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

Mci 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 b984dece-4920-4622-b60d-9da947fca8c7 34 fields · synced May 31, 2026