BioGlue Surgical Adhesive BG3515-5-US

GUDID 20877234001301

5mL Syringe and Standard Applicator Tips

Artivion, Inc.

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: 20877234001301
• NIH Device Record Key: bc5f1716-f60a-44ba-a425-6848b577fb3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioGlue Surgical Adhesive
• Version Model Number: BG3515-5-US
• Catalog Number: BG3515-5-US
• Company DUNS: 119253177
• Company Name: Artivion, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com
• Phone: 7704193355
• Email: customerservice.us@artivion.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10877234001304 [Primary]
GS1	20877234001301 [Package]; Contains: 10877234001304; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010003

FDA Product Code

• MUQ: Glue, Surgical, Arteries

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: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [BioGlue Surgical Adhesive]

• 10877234001311: 2mL Syringe and Standard Applicator Tips
• 20877234001301: 5mL Syringe and Standard Applicator Tips
• 20877234001295: 10mL Syringe with Standard Applicator Tips
• 10877234001182: BioGlue Surgical Adhesive Applicator Tips
• 10877234000949: BioGlue Surgical Adhesive Delivery Tip Extension
• 10877234000932: BioGlue Surgical Adhesive Delivery Tip Extension
• 10877234000925: BioGlue Surgical Adhesive Syringe Spreader Tips
• 10877234000918: BioGlue Surgical Adhesive Syringe Spreader Tips
• 10877234000901: BioGlue Surgical Adhesive Syringe Extender Tips
• 10877234000895: BioGlue Surgical Adhesive Syringe Extender Tips