FDA.reportPublic FDA data

Spectrum IQ

Primary DI
00085412610900
Brand
Spectrum IQ
Company
BAXTER HEALTHCARE CORPORATION
Model
3570009
Catalog number
3570009
Device description
The Spectrum IQ Infusion System with Dose IQ Safety Software is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum IQ infusion pump is specifically manufactured and calibrated for use with Baxter administration sets.
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion
PHCInfusion safety management software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
PHCInfusion Safety Management SoftwareGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173084000Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation2018-05-11FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085412610900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085412610900000854126109000854126109000085412610900

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, line-poweredA mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent relative humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303MEDINFO_MEDPRODUCTS@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
00085412004747INTERLINK2N33392N33392016-09-24
00085412004785INTERLINK2N33432N33432016-09-24
00085412004792MICRO-VOLUME2N33452N33452016-09-24
00085412004808Baxter2N33462N33462016-09-24
00085412004815Micro-Volume2N33472N33472016-09-24
00085412004839Baxter2N33492N33492016-09-24
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

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10887709146980LifeShield Infusion Safety Software Suite - CDRICU Medical, Inc.PHC2026-10-23
10887709155050LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2026-10-23
10885403532948BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-22
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
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10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
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10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
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00860006582012TigerConnect Alarm ManagementCritical AlertPHC2026-05-29
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17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
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10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
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