| Primary Device ID | 00714646000828 |
| NIH Device Record Key | 419ffd29-9a99-44f2-8e49-85b8b8a0db79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sample AlphaCleanse® Antimicrobial Wound Care System |
| Version Model Number | SP-25750 |
| Catalog Number | 25750 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature away from direct sunlight, do not freeze |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00714646000828 [Primary] |
| FQH | LAVAGE, JET |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
[00714646000828]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2022-10-27 |
| 00714646000606 - Igloo Wound Irrigator | 2024-10-03 Wound Irrigation - Sample |
| 10714646000665 - ShotBlocker® | 2024-09-26 5 ct ShotBlocker |
| 10714646000849 - ShotBlocker® | 2024-09-26 ShotBlocker® 2000 ct. Retail |
| 20714646000860 - SafeStraw™ 2 Pack | 2024-09-26 SafeStraw™ 2 Pack |
| 10714646000993 - Opti-Tatt™ Dots | 2024-09-26 Opti-Tatt, Dot, Sheet of 24 |
| 10714646001006 - Opti-Tatt™ Crosshairs | 2024-09-26 Opti-Tatt, Crosshair, Sheet of 24 |
| 10714646001013 - Opti-Tatt™ Field Borders | 2024-09-26 Opti-Tatt, Field Border, Sheet of 24 |
| 10714646001020 - Sample: Opti-Tatt Dots | 2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3 |