FDA UDI
In Commercial Distribution
🇺🇸 United States
Electric single chiller
DI: 00810072351210
·
Model: Electric single chiller
·
Cole Instruments Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Electric single chiller
- Primary DI
- 00810072351210
- Version / Model
- Electric single chiller
- Catalog Number
- 700.000
- Company Name
- Cole Instruments Inc
- Labeler DUNS
- 078573265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 0799f211-6214-4711-b97d-ce357e9e43e3
Device Description
Device is used to chill follicles in between the extraction from the donor area and insertion in the recipient area for hair transplantation.
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
- No
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60262 | Cooling laboratory mixer | A mains electricity (AC-powered) electromechanical device intended to be used in the clinical laboratory to mix two or more materials under regulated cool/cold temperatures (e.g., between 2? and 20? Celsius). It typically includes mixing and cooling modules; a microcontroller for process automation, temperature monitoring, and with timer/alarm; solution vial holder; and sometimes an injection pump. The device is often used for the cryopreparation of cord blood units for stem cell cryopreservation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810072351210 | GS1 |