CLEARLINK 2R8403

GUDID 50085412656644

CLEARLINK System. Non-DEHP Solution Set with DUO-VENT Spike

BAXTER HEALTHCARE CORPORATION

Intravenous administration set

• Primary Device ID: 50085412656644
• NIH Device Record Key: 6972ccc6-9e9e-47c0-b43e-3e4bee3d0473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARLINK
• Version Model Number: 2R8403
• Catalog Number: 2R8403
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412656649 [Primary]
GS1	50085412656644 [Package]; Contains: 00085412656649; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112893

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-05-31

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• 50197886004361 - CLEARLINK/CONTINU-FLO: 2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 9
• 10085412676613 - DOSE IQ SAFETY SOFTWARE: 2024-04-30 Infusion Safety Management Software
• 05413765851797 - Novum IQ: 2024-04-18 The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a
• 51978860004350 - CLEARLINK/CONTINU-FLO: 2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1