BlastX™

GUDID 00864076000285

NEXT SCIENCE, LLC

Wound hydrogel dressing, non-sterile, antimicrobial

• Primary Device ID: 00864076000285
• NIH Device Record Key: 833b62bf-c66e-4b36-b368-3cd2320116f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlastX™
• Version Model Number: MC-WG-0003-12
• Company DUNS: 043989331
• Company Name: NEXT SCIENCE, LLC
• Device Count: 12
• 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: true
• Single Use: false
• 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

Device Dimensions

• Total Volume: 7.5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370858000126 [Unit of Use]
GS1	00864076000285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163188

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-15

On-Brand Devices [BlastX™]

• 00370858000096: MC-WG-0003-80
• 00370858000089: MC-WG-0003-40
• 00370858000072: MC-WG-0011-30
• 00864076000285: MC-WG-0003-12
• 00864076000216: WG-0001