FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific
DI: 10816934021168
·
Model: TSX5004BZ
·
KEY SCIENTIFIC INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Thermo Scientific
- Primary DI
- 10816934021168
- Version / Model
- TSX5004BZ
- Catalog Number
- TSX5004BZ
- Company Name
- KEY SCIENTIFIC INC
- Labeler DUNS
- 938286804
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-14
- Public Version
- 2
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- e45865a8-d40b-402a-aace-aa8ce9e05939
Device Description
Thermo Scientific TSX Series high-performance blood bank refrigerator
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 |
|---|---|---|---|---|
| KSE | Refrigerator, Freezer, Blood Storage | Hematology | 864.9700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35486 | Blood refrigerator | An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10816934021168 | GS1 |
Customer Contacts
- Phone
- 1-866-984-3766
- [email protected]