FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific ™ CryoMed™
DI: 00815773020328
·
Model: TSCM48EA
·
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermo Scientific ™ CryoMed™
- Primary DI
- 00815773020328
- Version / Model
- TSCM48EA
- Catalog Number
- TSCM48EA
- Company Name
- THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
- Labeler DUNS
- 791530061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-05
- Public Version
- 1
- Public Version Date
- 2021-01-13
- Public Version Status
- New
- Public Device Record Key
- aaaff3fe-9515-4649-b547-2daad86d8e0b
Device Description
TSCM48EA; CryoMed MD 48L W/ Print, 120V/60Hz
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 |
|---|---|---|---|---|
| 22073 | Cryogenic laboratory freezer, liquid nitrogen | A mains electricity (AC-powered) laboratory appliance designed for extended cell/tissue (e.g., ovum, embryo, bone, cornea) storage, at temperatures below the point when most all biological activity ceases, using liquid nitrogen (LN2) as the cooling and storage agent. LN2 storage provides a temperature of -180? Celsius (-292? Fahrenheit) or colder. The device typically consists of a chamber with two vessels separated by a vacuum space; automatic temperature controls; an external container to replenish the cryogenic fluid; a pressure-relief device, alarm, recorder; and a pressure-control valve. Cells/tissues are immersed in the liquid nitrogen using appropriate sealed containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815773020328 | GS1 |
Customer Contacts
- Phone
- 7405165628
- [email protected]