FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AlphaCleanse
DI: 00714646000828
·
Model: 25750
·
Bionix, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AlphaCleanse
- Primary DI
- 00714646000828
- Version / Model
- 25750
- Catalog Number
- 25750
- Company Name
- Bionix, LLC
- Labeler DUNS
- 117844489
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-27
- Public Version
- 4
- Public Version Date
- 2024-01-08
- Public Version Status
- Update
- Public Device Record Key
- 419ffd29-9a99-44f2-8e49-85b8b8a0db79
- Distribution End Date
- 2024-01-03
Device Description
Sample, AlphaCleanse Antimicrobial Wound Care System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14462 | Wound irrigation kit | A collection of noninvasive devices intended to be used by a healthcare professional to irrigate/cleanse an acute, chronic, or surgical wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00714646000828 | GS1 |
Customer Contacts
- Phone
- +1(800)551-7096
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 8 | Fluid Ounce |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room temperature away from direct sunlight, do not freeze
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit