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Novum IQ

FDA UDI

Class II (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
Novum IQ FDA UDI
Generic Name
Bedside syringe pump FDA UDI
Device Name
The Novum IQ Syringe Pump is software controlled Syringe 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
40800BAXUSRP FDA UDI
Description
The Novum IQ Syringe Pump is software controlled Syringe 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
40800BAXUSRP FDA UDI
Primary DI / UDI-DI
00197886008210 FDA UDI
510(k) Number
K242390 FDA UDI
FDA Product Code
FRN FDA UDI
LZH FDA UDI
GMDN Term
Bedside syringe pump 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Bedside syringe pump

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

Similar devices

Also classified as Bedside syringe pump.

Cleared under the same submission

K242390 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA UDI 8b83346a-7f3d-4cbf-be0f-6ff0fa64554c 37 fields · synced Jun 8, 2026