CLEARLINK/CONTINU-FLO ALT2403

GUDID 51978860004350

QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 109” (2.8 m), 17.2 mL, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar.

BAXTER HEALTHCARE CORPORATION

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• Primary Device ID: 51978860004350
• NIH Device Record Key: baa39b2c-180d-4efe-9944-af3e122c4cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARLINK/CONTINU-FLO
• Version Model Number: ALT2403
• Catalog Number: ALT2403
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	01978860004355 [Primary]
GS1	51978860004350 [Package]; Contains: 01978860004355; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203609

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [CLEARLINK/CONTINU-FLO]

• 51978860004367: QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Sol
• 51978860004350: QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Sol