FDA UDI
In Commercial Distribution
🇺🇸 United States
Freedom EVO®
DI: 07640137480110
·
Model: FREEDOM EVO-2 200 BASE
·
Tecan Schweiz AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Freedom EVO®
- Primary DI
- 07640137480110
- Version / Model
- FREEDOM EVO-2 200 BASE
- Catalog Number
- 10641202
- Company Name
- Tecan Schweiz AG
- Labeler DUNS
- 481151509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-22
- Public Version
- 1
- Public Version Date
- 2021-12-30
- Public Version Status
- New
- Public Device Record Key
- 57c52568-7207-4750-bfaf-e7b2dfd0d1b1
Device Description
configurable liquid handling workstation
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | Clinical Chemistry | 862.2750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65174 | Pipetting system IVD | An electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640137480110 | GS1 |
Customer Contacts
- Phone
- +41449228282
- [email protected]