FDA UDI
In Commercial Distribution
🇺🇸 United States
Citrajet
DI: 00660483200115
·
Model: 1 Gallon
·
ALCONOX INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Citrajet
- Primary DI
- 00660483200115
- Version / Model
- 1 Gallon
- Catalog Number
- 2001-1
- Company Name
- ALCONOX INC
- Labeler DUNS
- 001478726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-08
- Public Version
- 1
- Public Version Date
- 2020-10-16
- Public Version Status
- New
- Public Device Record Key
- cbb32852-1818-455d-87fb-24e01c20aef6
Device Description
Cleaner for ultrasonic cleaning of medical devices
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | 880.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58061 | Instrument rinsing agent | A liquid substance with a neutral or acidic pH intended for the rinsing of medical/surgical instruments (e.g., specula, forceps) after machine cleaning and prior to full sterilization. It is typically a phosphoric acid (H3PO4) in an aqueous solution that neutralizes the alkaline residues from detergents and water (acidic rinse), or lubricants and drying activators (neutral rinse) and may be added, as specified by the manufacturer, to an automated washer. 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 | 00660483200115 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius