Novum IQ 40800BAXUSRF

GUDID 20197886008207

The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725.

BAXTER HEALTHCARE CORPORATION

Bedside syringe pump

• Primary Device ID: 20197886008207
• NIH Device Record Key: 9eddc204-d22c-40dd-bef2-53f65581b0c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novum IQ
• Version Model Number: 40800BAXUSRF
• Catalog Number: 40800BAXUSRF
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• 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)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com
• Phone: +1(800)843-7867
• Email: PumpSupport@Baxter.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from Sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197886008203 [Primary]
GS1	20197886008207 [Package]; Contains: 00197886008203; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242390

FDA Product Code

• LZH: Pump, infusion, enteral

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-15
• Device Publish Date: 2025-07-07

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