FDA UDI
In Commercial Distribution
🇺🇸 United States
DISP FL (conc.)
DI: 05055273202656
·
Model: EV3580
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DISP FL (conc.)
- Primary DI
- 05055273202656
- Version / Model
- EV3580
- Catalog Number
- EV3580
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 3
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 869c4687-6b49-421f-b056-37402242535c
Device Description
Diluted displacement fluid is used to wash the Evidence™ reagent tubing between dispenses.
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
- 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 |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 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 |
|---|---|---|---|---|---|---|
| Primary | 05055273202656 | GS1 |
Customer Contacts
- Phone
- +44289445170
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030360 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The working solution is stable onboard the Evidence™ analyser at room temperature for 48 hours.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius