TISSEEL/ARTISS SPRAY SET 1504266

GUDID 55413765583433

Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and a clip to be attached to the double syringe system plunger for gas activation.

BAXTER HEALTHCARE CORPORATION

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 55413765583433
• NIH Device Record Key: efd3eadf-2f00-4e77-9a10-db68e7968b77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TISSEEL/ARTISS SPRAY SET
• Version Model Number: 1504266
• Catalog Number: 1504266
• 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(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com
• Phone: +1(888)229-0001
• Email: medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765583438 [Primary]
GS1	55413765583433 [Package]; Contains: 05413765583438; Package: CASE [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050495

FDA Product Code

• FMF: Syringe, piston

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: 2020-10-08
• Device Publish Date: 2020-09-30

Devices Manufactured by BAXTER HEALTHCARE CORPORATION

• 05413765852428 - Novum IQ: 2024-09-23 The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient
• 20085412676610 - DOSE IQ SAFETY SOFTWARE: 2024-09-02 Infusion Safety Management Software
• 20085412841629 - MINICAP EXTENDED LIFE PD TRNS: 2024-08-13 This set consists of a female locking connector/on-off clamp assembly, tubing and double sealing male Luer lock connector. This
• 50197886004354 - 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, 1
• 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