PREVELEAK SURGICAL SEALANT ADS201810

GUDID 25413765583609

Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.

Baxter Healthcare Corporation

Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived Surgical internal adhesive/sealant, animal-derived

• Primary Device ID: 25413765583609
• NIH Device Record Key: c3c13b6b-76ad-4131-b9e3-3658daf0fa1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVELEAK SURGICAL SEALANT
• Version Model Number: ADS201810
• Catalog Number: ADS201810
• Company DUNS: 117472302
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765583605 [Primary]
GS1	25413765583609 [Package]; Contains: 05413765583605; Package: PACK_OR_INNER_PACK [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100030

FDA Product Code

• NBE: Sealant, polymerizing

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: 2021-06-09
• Device Publish Date: 2021-06-01

On-Brand Devices [PREVELEAK SURGICAL SEALANT]

• 25413765583609: Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical re
• 25413765583593: Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical re
• 25413765583586: Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical re
• 25413765583524: The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with