FDA UDI
In Commercial Distribution
🇺🇸 United States
Cleaning Solution
DI: 25999883586581
·
Model: VA0000SL
·
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cleaning Solution
- Primary DI
- 25999883586581
- Version / Model
- VA0000SL
- Catalog Number
- VA0000SL
- Company Name
- Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
- Labeler DUNS
- 427395277
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-24
- Public Version
- 1
- Public Version Date
- 2023-05-02
- Public Version Status
- New
- Public Device Record Key
- e78b237f-b290-4a3e-84f3-5c6f4910eb7c
Device Description
Cleaning kit contains stabilized and micro-filtered hypochlorite and detergents, for regular cleaning and rinsing of clinical chemistry analyzers’ probes, cuvettes, and tubings removing reagents, samples and protein deposits.
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
- No
- 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 |
|---|---|---|---|---|
| JCB | Detergent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59058 | Wash/cleaning solution IVD, automated/semi-automated system | A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35999883586588 | GS1 | Cardboard | 6 | In Commercial Distribution | |
| Primary | 25999883586581 | GS1 |
Customer Contacts
- Phone
- +3612794400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 250 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 32 Degrees Celsius