FDA.reportPublic FDA data

Novum IQ

Primary DI
00197886013177
Brand
Novum IQ
Company
BAXTER HEALTHCARE CORPORATION
Model
40700BAXUSD
Catalog number
40700BAXUSD
Device 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.
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211122000Novum IQ Large Volume PumpBaxter Healthcare Corporation2024-03-29FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197886013172PackageGS11In Commercial Distribution
00197886013177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5019788601317250197886013172
00197886013177001978860131771978860131770197886013177

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, single-channelAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY. KEEP AWAY FROM SUNLIGHT.
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius49 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
005083209
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412036373INTERLINK2C75572C75572016-09-24
00085412036380INTERLINK2C75582C75582016-09-24
00085412046372CLEARLINK2C88572C88572016-09-24
00085412071688CLEARLINK2C88582C88582016-09-24
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24
00085412048963CLEARLINK2C86102C86102016-09-24
00085412049007CLEARLINK2C86322C86322016-09-24
00085412049014CLEARLINK2C86062C86062016-09-24
00085412051727CLEARLINK1C86931C86932016-09-24
00085412070056CLEARLINK2C86122C86122016-09-24
00085412071671CLEARLINK2C86072C86072016-09-24

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Primary DI, Brand, Company table
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10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20