FDA.reportPublic FDA data

Novum IQ

Primary DI
20197886008207
Brand
Novum IQ
Company
BAXTER HEALTHCARE CORPORATION
Model
40800BAXUSRF
Catalog number
40800BAXUSRF
Device 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.
Published
2025-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZHPump, infusion, enteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZHPump, Infusion, EnteralGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242390000Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation2024-09-05FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197886008207PackageGS11In Commercial Distribution
00197886008203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019788600820720197886008207
00197886008203001978860082031978860082030197886008203

GMDN Terms#

Term, Definition table
TermDefinition
Bedside syringe pumpA mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from Sunlight.
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)843-7867PumpSupport@Baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253009675KangarooCardinal Health 200, LLCLZH2026-05-12
10885380193071KangarooCardinal Health 200, LLCLZH2026-03-16
50885380193079KangarooCardinal Health 200, LLCLZH2026-03-16
10192253068900KangarooCardinal Health 200, LLCLZH2025-09-30
10192253068917KangarooCardinal Health 200, LLCLZH2025-09-30
00197886002300Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008203Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008210Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886002304Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00704411019797SENTINEL® Enteral Feeding PumpAMSINO INTERNATIONAL, INC.LZH2025-06-25
03660812138345PUGGLEMEDWIN FRANCELZH2025-06-11
53660812136780PUGGLEMEDWIN FRANCELZH2025-06-11
10192253011135KangarooCardinal Health 200, LLCLZH2025-05-28
50192253011133KangarooCardinal Health 200, LLCLZH2025-05-28
10192253008456KangarooCardinal Health 200, LLCLZH2025-05-19
50192253008454KangarooCardinal Health 200, LLCLZH2025-05-19
10192253009682KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009859KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009965KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009680KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009857KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009963KangarooCardinal Health 200, LLCLZH2025-05-02
10192253008418KangarooCardinal Health 200, LLCLZH2025-04-29
10192253008432KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008416KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008430KangarooCardinal Health 200, LLCLZH2025-04-29
10885380184567KangarooCardinal Health 200, LLCLZH2025-03-23
10192253008159KangarooCardinal Health 200, LLCLZH2024-12-16
10192253023107KangarooCardinal Health 200, LLCLZH2024-12-16
10192253008371KangarooCardinal Health 200, LLCLZH2024-11-22