Chattanooga
Colpac Freezer, C/W 12 STD. Co Lpacs US STD
3manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (2), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen City U-Lucky Sporting Goods Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Dongguan Quanding Medical Supplies Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Linjiang (Holdings) Limited | Shangqiu | Henan | Private-label distributor | 11 |
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | IMF |
| Device type | Unit, Chilling |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5940 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-31 |
| Record revised | 2022-06-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90910 | In distribution | |
| 3114 | In distribution | |
| 3102 | In distribution |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-06-25 | Class II | Process change control | The device accessories were not labeled with appropriate latex warning. | 41,801 units | 2022-11-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.