FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Thermo Scientific Sorvall Blood Washing System
DI: 10816934020772
·
Model: CW2 Plus
·
KEY SCIENTIFIC INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermo Scientific Sorvall Blood Washing System
- Primary DI
- 10816934020772
- Version / Model
- CW2 Plus
- Catalog Number
- 80300566, 80300567
- Company Name
- KEY SCIENTIFIC INC
- Labeler DUNS
- 938286804
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-11-06
- Public Version Status
- Update
- Public Device Record Key
- a9057869-6593-4268-ab14-2a2fde03cbc0
- Distribution End Date
- 2019-11-05
Device Description
Sorvall Cell Washer 2+ ,100/120/240V 60Hz
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KSN | Centrifuge, Cell-Washing, Automated For Immuno-Hematology | Hematology | 864.9285 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35901 | Cell washer IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to separate red blood cells from whole blood and wash the intact red blood cells, typically through low-speed centrifugal force, to remove plasma, debris and/or any other extraneous material so they are free from interfering substances and suitable for use in subsequent in vitro clinical testing (e.g., antiglobulin). The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10816934020772 | GS1 |
Customer Contacts
- Phone
- 828-658-4400
- [email protected]