FDA UDI
In Commercial Distribution
🇺🇸 United States
CELLSHEATH
DI: 04987562406005
·
Model: 05404811
·
SYSMEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CELLSHEATH
- Primary DI
- 04987562406005
- Version / Model
- 05404811
- Company Name
- SYSMEX CORPORATION
- Labeler DUNS
- 690664461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 295cd126-b456-46d6-a6d4-ba1aa5ff8dfa
Device Description
CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex. Use as a sheath fluid for hematology analyzer.
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 |
|---|---|---|---|---|---|---|
| Primary | 04987562406005 | GS1 |
Customer Contacts
- Phone
- +1(888)879-7644
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius