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 General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 00085412091570
• NIH Device Record Key: acce253b-2577-4b0e-9ed4-1b1045547092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECTRUM WITH MDL
• Version Model Number: 35700BAX
• Catalog Number: 35700BAX
• 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: true
• 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
• 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 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Agency	Device ID
GS1	00085412091570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042121

FDA Product Code

• FRN: Pump, infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-20
• 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