AlphaCleanse™ Antimicrobial Wound Care System
GUDID 10714646000801
Antimicrobial wound irrigation and cleansing system
Bionix, LLC
Wound irrigation kit| Primary Device ID | 10714646000801 |
| NIH Device Record Key | b12e2884-eb0b-47f2-8d7c-28e19af1808b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AlphaCleanse™ Antimicrobial Wound Care System |
| Version Model Number | WI-05750 |
| Company DUNS | 117844489 |
| Company Name | Bionix, 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 | true |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | +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 |
Device Dimensions
| 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 |
| 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 |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
| Total Volume | 8 Fluid Ounce |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00714646000804 [Primary] |
| GS1 | 10714646000801 [Package] Contains: 00714646000804 Package: CASE [12 Units] In Commercial Distribution |
FDA Product Code
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2021-11-18 |
Devices Manufactured by Bionix, LLC
| 10714646000542 - Lighted Ear Curette Demo Pack | 2024-07-18 Lighted Ear Curette Demo Pack |
| 00714646000552 - Sample, Lighted FlexLoop | 2024-07-18 Sample, Lighted FlexLoop |
| 10714646000566 - Sample, Safe Ear Curette Rainbow Pack | 2024-07-18 Sample, Safe Ear Curette Rainbow Pack |
| 10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer) | 2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer) |
| 00714646001085 - Sample, Lighted Suction Handle | 2024-07-18 Sample, Lighted Suction Handle |
| 00714646001252 - Lighted Articulating - Sample | 2024-06-24 Lighted Articulating Curette - Sample |
| 10714646001198 - SecureFoam | 2024-06-10 SecureFoam - Small |
| 10714646001204 - SecureFoam | 2024-06-10 SecureFoam - Medium |
Trademark Results [AlphaCleanse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALPHACLEANSE 90546897 not registered Live/Pending |
Bionix, LLC 2021-02-25 |
 ALPHACLEANSE 90494662 not registered Live/Pending |
Bionix Development Corporation 2021-01-28 |
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