FDA UDI
In Commercial Distribution
🇺🇸 United States
iClean
DI: 16974488990331
·
Model: CY-F002-35
·
Huachenyang (Shenzhen) Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- iClean
- Primary DI
- 16974488990331
- Version / Model
- CY-F002-35
- Company Name
- Huachenyang (Shenzhen) Technology Co., Ltd
- Labeler DUNS
- 548237157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- e72d7a22-031d-4a74-bffa-86835c9ce064
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | Hematology | 864.2875 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52735 | Cell preservation/storage/dilution solution IVD | A solution intended to be used for the preservation, storage, washing, dilution and/or resuspension of cells (e.g., red and/or white blood cells, epithelial, bacterial, fungal, etc.) in a clinical specimen or a cell isolate, to maintain cell stability and/or facilitate further in vitro diagnostic testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26974488990338 | GS1 | carton | 10 | In Commercial Distribution | |
| Primary | 16974488990331 | GS1 | ||||
| Unit of Use | 06974488990334 | GS1 |