SPECTRUM WITH MDL 35700BAX

GUDID 00085412091570

The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling.

BAXTER INTERNATIONAL INC.

General-purpose infusion pump, line-powered
Primary Device ID00085412091570
NIH Device Record Keyacce253b-2577-4b0e-9ed4-1b1045547092
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPECTRUM WITH MDL
Version Model Number35700BAX
Catalog Number35700BAX
Company DUNS079209157
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH
Special Storage Condition, SpecifyBetween 0 and 0 *Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with Standard Battery from 10 to 90 %RH

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412091570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-20
Device Publish Date2016-09-24

Devices Manufactured by BAXTER INTERNATIONAL INC.

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