Bactisure™
GUDID 00864076000209
NEXT SCIENCE, LLC
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 |
| info@nextscience.com | |
| Phone | 855-564-2762 |
| info@nextscience.com | |
| Phone | 855-564-2762 |
| info@nextscience.com | |
| Phone | 855-564-2762 |
| 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 |
Trademark Results [Bactisure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BACTISURE 88201140 not registered Live/Pending |
Zimmer, Inc. 2018-11-20 |
 BACTISURE 86515159 not registered Dead/Abandoned |
Zimmer, Inc. 2015-01-27 |
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