NANO DIGITCOOL FREEZER
- Primary DI
- 03661532003159
- Company
- CRYO BIO SYSTEM
- Model
- 2
- Catalog number
- 025680
- Published
- 2020-10-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 500731872
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03661532003159 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 03661532003159 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| PUB | Accessory, Assisted Reproduction, Exempt | 2 | Obstetrics/Gynecology | 884.6120 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Cryogenic laboratory freezer, vapour-phase 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 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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 03661532002077 | STERILE CBS HIGH SECURITY TISSUE 2 ML STRAW / BY 20 | 1 | 018960 | 2020-12-07 |
| 03661532000301 | STERILE CBS 0.3ML STRAW FOR SPERM WITHOUT JACKET WHITE PLUG - 4X5 | 1 | 010287 | 2020-10-30 |
| 03661532000325 | STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20 | 1 | 010288 | 2020-10-30 |
| 03661532000332 | STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20 | 1 | 014650 | 2020-10-30 |
| 03661532002626 | CBS Non-Sterile High Security Tube | 1 | 022251 | 2020-10-30 |
| 03661532002633 | CBS STERILE HIGH SECURITY TUBE BY 20 UNITS | 1 | 022252 | 2020-10-30 |
| 03661532002657 | CBS STERILE HIGH SECURITY TUBE BY 50 UNITS | 1 | 023722 | 2020-10-30 |
| 03661532002947 | CBS STERILE FILLING NOZZLE - BOX 100 | 1 | 024856 | 2020-10-30 |
| 03661532002954 | CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x1 | 1 | 025292 | 2020-10-30 |
| 03661532002985 | BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - YELLOW | 1 | 025248 | 2020-10-30 |
| 03661532002992 | BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - PINK | 1 | 025249 | 2020-10-30 |
| 03661532003005 | BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - BLUE | 1 | 025250 | 2020-10-30 |
| 03661532003012 | BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - GREEN | 1 | 025251 | 2020-10-30 |
| 03661532003067 | CBS INTEGRAL FREEZER | 2 | 027807 | 2020-10-30 |
| 03661532002961 | BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - RED | 1 | 025246 | 2020-10-29 |
| 03661532002978 | BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - WHITE | 1 | 025247 | 2020-10-29 |
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