AVID TruCustom

FDA UDI

Class II (US FDA UDI)

by Avid Medical, Inc.

Identity

Trade Name: AVID TruCustom FDA UDI
Generic Name: General-purpose catheter connector, sterile FDA UDI
Model / Reference: RMRI100_0001 FDA UDI

Identifiers

Primary DI / UDI-DI: 10809160168844 FDA UDI
510(k) Number: K810921 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: General-purpose catheter connector, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: General-purpose catheter connector, sterile

AVID TruCustom by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as General-purpose catheter connector, sterile.

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PLEUR-EVAC — TELEFLEX INCORPORATED · Class II
Magellan™ — Hansen Medical, Inc. · Class II
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Fluid Dock — Boston Scientific · Class II
Custom Medical Specialties, Inc. — CUSTOM ASSEMBLIES, INC. · Class I

Cleared under the same submission

K810921 also covers:

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 9e4ee1d0-d06d-49f7-94ab-81f620331c2c 33 fields · synced May 30, 2026