SIGMA Spectrum Infusion Pump 35700BAX2

GUDID 00085412498683

The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library provides delivery of fluids in a controlled manner. It is a software controlled electromechanical device used for infusion of pharmaceutical drugs, blood, blood products and mixtures of patient therapy through administration sets.

BAXTER INTERNATIONAL INC.

General-purpose infusion pump, line-powered

• Primary Device ID: 00085412498683
• NIH Device Record Key: 753fa5b0-6dba-42d3-8deb-f49e680e52fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA Spectrum Infusion Pump
• Version Model Number: 35700BAX2
• Catalog Number: 35700BAX2
• Company DUNS: 079209157
• Company Name: BAXTER INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from -10 to 49 degrees celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Remove the battery module from the pump when storing for extended periods of time
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 10 to 90 percent relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Device Stored with Standard Battery from 14 to 120 degrees fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412498683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133801

FDA Product Code

• PHC: Infusion safety management software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by BAXTER INTERNATIONAL INC.

• 50085412676628 - CLR1 - CLEARLINK: 2023-07-24 Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 100” (2.5m) approx., 10 drops/mL
• 50085412002335 - INTERLINK: 2020-06-30 Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar
• 50085412031199 - INTERLINK: 2020-06-30 Y-Type Blood/Solution Set, 40 and 150 Micron Dual Screen Filter, Injection Site, Male Luer Lock Adapter with Retractable Collar
• 50085412065293 - INTERLINK: 2020-06-30 Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter wi
• 50085412046162 - NA: 2020-05-06 Evacuated Container, 1000 mL
• 50085412565625 - NA: 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412565946 - NA: 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412000522 - INTERLINK/CONTINU-FLO: 2019-12-11 Non-DEHP CONTINU-FLO Solution Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar