FDA UDI
In Commercial Distribution
🇺🇸 United States
Conveyor 600, TCA
DI: 06438153000211
·
Model: 1
·
Thermo Fisher Scientific Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Conveyor 600, TCA
- Primary DI
- 06438153000211
- Version / Model
- 1
- Catalog Number
- 952021
- Company Name
- Thermo Fisher Scientific Oy
- Labeler DUNS
- 540096708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-26
- Public Version
- 1
- Public Version Date
- 2023-08-03
- Public Version Status
- New
- Public Device Record Key
- 90892ea1-b4e7-47df-b170-308f68817e87
Device Description
Conveyor 600, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices.
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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57871 | Specimen processing instrument IVD | An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438153000211 | GS1 |