AVID TruCustom

FDA UDI

Class II (US FDA UDI)

by Avid Medical, Inc.

Identity

Trade Name: AVID TruCustom FDA UDI
Generic Name: Central venous catheterization kit, short-term FDA UDI
Model / Reference: VANW017_0007 FDA UDI

Identifiers

Catalog Number: VANW017 FDA UDI
Primary DI / UDI-DI: 10809160099728 FDA UDI
FDA Product Code: OES FDA UDI
GMDN Term: Central venous catheterization kit, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Sterilization Method

Ethylene Oxide FDA UDI

Category: Central venous catheterization kit, short-term

The AVID TruCustom device is a high-quality, single-use cardiac catheterization kit designed for short-term use in the introduction of central venous catheters. With its sterile and non-sterile versions available, this device caters to various infusion and aspiration procedures. As a compliant product with GS1 identifiers, the AVID TruCustom has been in commercial distribution for several years.

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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: Avid Medical, Inc.

Sources (1)

FDA UDI 27c3b339-001e-4cd4-a243-4c364dce16df 34 fields · synced Jul 24, 2026