FDA UDI
In Commercial Distribution
🇺🇸 United States
NANO DIGITCOOL FREEZER
DI: 03661532003159
·
Model: 2
·
CRYO BIO SYSTEM
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NANO DIGITCOOL FREEZER
- Primary DI
- 03661532003159
- Version / Model
- 2
- Catalog Number
- 025680
- Company Name
- CRYO BIO SYSTEM
- Labeler DUNS
- 500731872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 2
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 6185ac60-3ee2-4b34-b487-92e284343ee2
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 |
|---|---|---|---|---|
| PUB | Accessory, Assisted Reproduction, Exempt | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 22074 | Cryogenic laboratory freezer, vapour-phase nitrogen | An electrically-powered laboratory appliance designed for extended cell/tissue (e.g., ovum, embryo, bone, cornea) storage, at temperatures below the point where most all biological activity ceases, using liquid nitrogen (LN2) as the cooling agent and vapour-stage nitrogen for storage [storage temperature of -140° Celsius (-220° Fahrenheit)]. 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 vapour atmosphere above the LN2 in appropriate containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661532003159 | GS1 |