FDA UDI
In Commercial Distribution
🇺🇸 United States
TOMCAT SYSTEM
DI: 15420045504677
·
Model: TOMCAT SYSTEM
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TOMCAT SYSTEM
- Primary DI
- 15420045504677
- Version / Model
- TOMCAT SYSTEM
- Catalog Number
- ASY-07379
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-09
- Public Version
- 6
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- f926ebee-6342-4ad6-9e10-0a048bf4d551
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | Clinical Chemistry | 862.2750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58025 | Laboratory container/microscope slide robotic transfer system IVD | An assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045504677 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius