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Transvalvular Insertion Tool (TVI)

FDA UDI

Class I (US FDA UDI)

by Merit Medical

Identity

Trade Name
Transvalvular Insertion Tool (TVI) FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Model / Reference
00884450433072 FDA UDI

Identifiers

Catalog Number
TVI-07 FDA UDI
Primary DI / UDI-DI
00884450433072 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Transvalvular Insertion Tool (TVI) by Merit Medical — Class I — 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
Merit Medical

Sources (1)

  • FDA UDI 7b248266-8098-48c3-8d23-e1f2c899aa1d 33 fields · synced Jun 8, 2026