Ivenix, Inc.

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name: Ivenix, Inc. FDA UDI
Generic Name: Bedside infusion pump, single-channel FDA UDI
Device Name: LVP Charging Bracket FDA UDI
Model / Reference: BKT-0004 FDA UDI
Description: LVP Charging Bracket FDA UDI

Identifiers

Catalog Number: BKT-0004 FDA UDI
Primary DI / UDI-DI: 00811505030023 FDA UDI
FDA Product Code: FRN FDA UDI
GMDN Term: Bedside infusion pump, single-channel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bedside infusion pump, single-channel

Ivenix, Inc. by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bedside infusion pump, single-channel.

Klein Tumescent Infiltration Pump — HK SURGICAL INC. · Class II
CADD — ICU MEDICAL, INC. · Class II
Sapphire Epidural Infusion Kit - US — EITAN MEDICAL LTD · Class II
Plum — Hospira, Inc. · Class II
Plum — Hospira, Inc. · Class II
ICU Medical, INC. — ICU MEDICAL, INC. · Class II
CADD — ICU MEDICAL, INC. · Class II
BD® Alaris™ PCU Model 8015 — CareFusion 303, INC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fresenius Kabi

Sources (1)

FDA UDI 7669bd0d-adb8-40d7-9842-0753673d9b84 35 fields · synced Jun 8, 2026