FDA UDI
In Commercial Distribution
🇺🇸 United States
UF II PACK-SED
DI: 04987562408382
·
Model: 06401615
·
SYSMEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- UF II PACK-SED
- Primary DI
- 04987562408382
- Version / Model
- 06401615
- Company Name
- SYSMEX CORPORATION
- Labeler DUNS
- 690664461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- c9d27de1-a7be-4363-b548-5e5d53e4338b
Device Description
UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended for use only in conjunction with UFII SEARCH -SED. UFII PACK -SED dilutes the aspirated sample for the determination of the parameters, Red Blood Cell (RBC), White Blood Cell (WBC), Epithelial Cells (EC) and Casts (CAST) count, by fluorescence flow cytometry method.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GIF | Diluent, Blood Cell | Hematology | 864.8200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58237 | Buffered sample diluent IVD | A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 84987562408388 | GS1 | ||||
| Primary | 04987562408382 | GS1 |
Customer Contacts
- Phone
- +1(888)879-7644
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2.1 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 35 Degrees Celsius