Bactisure™

Basic Information

• Brand Name: Bactisure™
• Primary DI: 00864076000209
• Version / Model: 00-8887-001-00
• Company Name: NEXT SCIENCE, LLC
• Labeler DUNS: 043989331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-24
• Public Version: 2
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 369b323b-d421-4d6f-8f3b-806a0687892e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQH	Lavage, Jet	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57973	Antimicrobial wound irrigation solution, sterile	A sterile solution that includes an antimicrobial agent [e.g., polyhexanide (PHMB)] intended to be used to irrigate, clean/moisten, and decontaminate a wound or burn to aid in autolytic debridement, and to moisten/lubricate a wound dressing. It may be used for acute or chronic wounds, including first or second degree burns. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864076000209	GS1
Package	10864076000206	GS1		6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161165	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1000	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 30 Degrees Celsius