Trufreeze
16 Fr Active Venting Kit. 5 - 16 Fr Active Venting Cryo Decompression Tube (Low Durometer) 5 - Active Venting Catheter
3manufacturers in China registered for this device type
20catalogue numbers in this listing
14510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | CSA Medical, United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K162695 |
| Record published | 2016-09-16 |
| Record revised | 2022-04-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Dry / Away from sunlight; Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
| Distribution end date | 2022-04-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CD3-001 | Withdrawn | |
| 20-00183 | Withdrawn | |
| CD3-001 | Withdrawn | |
| CD3-001 | Withdrawn | |
| CC3-01 | Withdrawn | |
| 20-00181 | Withdrawn | |
| CD3-001 | Withdrawn | |
| CD3-001 | Withdrawn | |
| CD6-001 | Withdrawn | |
| 20-00184 | Withdrawn | |
| 20-00181 | Withdrawn | |
| CD6-001 | Withdrawn | |
| CD6-001 | Withdrawn | |
| 20-00184 | Withdrawn | |
| 20-00177 | Withdrawn | |
| 20-00183 | Withdrawn | |
| 20-00177 | Withdrawn | |
| CD3-001 | Withdrawn | |
| CD3-001 | Withdrawn | |
| 20-00180 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201183 | 2020-12-07 |
| K171626 | 2017-08-30 |
| K172041 | 2017-07-27 |
| K171522 | 2017-07-14 |
| K163244 | 2017-05-24 |
| K162695 | 2016-10-25 |
| K161557 | 2016-07-26 |
| K152668 | 2015-10-14 |
| K150920 | 2015-06-17 |
| K143625 | 2015-01-15 |
| K133258 | 2014-06-19 |
| K113021 | 2012-02-07 |
| K072651 | 2007-12-07 |
| K070893 | 2007-05-01 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2015-03-25 | Class II | Software design | TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax | 82 units | 2015-08-21 |
| 2014-11-10 | Class II | Software design | An increase in complaint trending for a loss of audible sound associated with the timer has been observed. | 46 | 2015-03-25 |
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.