Coseal Surgical Sealant 934071

GUDID 05413765404627

Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/

BAXTER HEALTHCARE CORPORATION

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 05413765404627
• NIH Device Record Key: e5876c6e-f8f8-4bfc-a087-651fd4dad0ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coseal Surgical Sealant
• Version Model Number: 934071
• Catalog Number: 934071
• Company DUNS: 628013963
• 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: 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

Device Dimensions

• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765404627 [Primary]

FDA Product Code

• NBE: Sealant,Polymerizing

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: 2018-03-29
• Device Publish Date: 2015-06-10

On-Brand Devices [Coseal Surgical Sealant]

• 05413765404634: Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dil
• 05413765404627: Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dil
• 05413765404610: Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dil