Bactisure™

GUDID 00864076000209

NEXT SCIENCE, LLC

Antimicrobial wound irrigation solution, sterile Antimicrobial wound irrigation solution, sterile Antimicrobial wound irrigation solution, sterile Antimicrobial wound irrigation solution, sterile

• Primary Device ID: 00864076000209
• NIH Device Record Key: 369b323b-d421-4d6f-8f3b-806a0687892e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bactisure™
• Version Model Number: 00-8887-001-00
• Company DUNS: 043989331
• Company Name: NEXT SCIENCE, LLC
• 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: 855-564-2762
• Email: info@nextscience.com
• Phone: 855-564-2762
• Email: info@nextscience.com
• Phone: 855-564-2762
• Email: info@nextscience.com
• Phone: 855-564-2762
• Email: info@nextscience.com

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864076000209 [Primary]
GS1	10864076000206 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161165

FDA Product Code

• FQH: Lavage, Jet

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: 2018-08-24
• Device Publish Date: 2018-07-24

On-Brand Devices [Bactisure™]

• 00864076000209: 00-8887-001-00
• 00864076000292: 00-8887-002-00