FDA.reportPublic FDA data

SIGMA Spectrum Infusion Pump

Primary DI
00085412498683
Brand
SIGMA Spectrum Infusion Pump
Company
BAXTER HEALTHCARE CORPORATION
Model
35700BAX2
Catalog number
35700BAX2
Device description
The SIGMA Spectrum Infusion Pump with Master Drug Library 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 infusion pump is specifically manufactured and calibrated for use with Baxter administration sets.
Published
2016-09-24
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
K133801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133801000BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYBaxter Healthcare Corporation2014-05-07FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085412498683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085412498683000854124986830854124986830085412498683

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Device Stored with Standard Battery from -10 to 49 degrees celsius
Special Storage Condition, Specify00Device Stored with Standard Battery from 10 to 90 percent relative humidity
Special Storage Condition, Specify00Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
Special Storage Condition, Specify00Device Stored with Wireless Battery from -10 to 49 degrees celsius
Special Storage Condition, Specify00Device Stored with Wireless Battery from 10 to 90 percent relative humidity
Special Storage Condition, Specify00Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
Special Storage Condition, Specify00Remove the battery module from the pump when storing for extended periods of time

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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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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10885403519499Alaris™ System Maintenance Software Kit, Model 8975CAREFUSION 303, INC.PHC2026-10-08
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
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