Novum IQ

FDA UDI

Class II (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name: Novum IQ FDA UDI
Generic Name: Bedside infusion pump, single-channel FDA UDI
Device Name: The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. FDA UDI
Model / Reference: 40700BAXUSRF FDA UDI
Description: The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. FDA UDI

Identifiers

Catalog Number: 40700BAXUSRF FDA UDI
Primary DI / UDI-DI: 00197886013184 FDA UDI
510(k) Number: K211122 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

MRI Safety

MR Unsafe FDA UDI

Category: Bedside infusion pump, single-channel

Novum IQ by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Plum — Hospira, Inc. · Class II
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BD® Alaris™ PCU Model 8015 — CareFusion 303, INC · Class II

Cleared under the same submission

K211122 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: Baxter Healthcare Corp

Sources (1)

FDA UDI 9c8925c0-a65d-48ab-bf0b-b87ad0064252 37 fields · synced May 29, 2026