TISSEEL/ARTISS SPRAY SET 1504265

GUDID 35413765583422

Tisseel/Artiss Spray Set 10 Pack

BAXTER HEALTHCARE CORPORATION

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 35413765583422
• NIH Device Record Key: ad085eef-c1d2-463d-911a-aa621068ff88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TISSEEL/ARTISS SPRAY SET
• Version Model Number: 1504265
• Catalog Number: 1504265
• 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(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 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765583421 [Primary]
GS1	35413765583422 [Package]; Contains: 05413765583421; Package: Pack [10 Units]; In Commercial Distribution
GS1	55413765583426 [Package]; Package: Case [3 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: 2025-01-10
• Device Publish Date: 2025-01-02

On-Brand Devices [TISSEEL/ARTISS SPRAY SET]

• 55413765583433: Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure lin
• 35413765583422: Tisseel/Artiss Spray Set 10 Pack