truFreeze 20-00184
GUDID 00857068006105
Rapid AV Catheter
Csa Medical, Inc.
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00857068006105 |
| NIH Device Record Key | ec6c51f6-a8da-459a-a23b-cc0ad671f28c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | truFreeze |
| Version Model Number | 20-00184 |
| Catalog Number | 20-00184 |
| Company DUNS | 621229413 |
| Company Name | Csa Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com | |
| Phone | 1-866-481-7786 |
| service@csamedical.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Dry / away from sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857068006105 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113021
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
[00857068006105]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-26 |
On-Brand Devices [truFreeze]
| 00857068006112 | Active Venting Catheter Qty 1 |
| 00857068006105 | Rapid AV Catheter |
| 00857068006099 | Rapid Av Active Venting Spray Kit - 5 Rapid AV Catheters, 5 Active Venting 16 Fr LD CDT |
| 00857068006082 | 16 Fr Active Venting Kit. 5 - 16 Fr Active Venting Cryo Decompression Tube (Low Durometer) 5 - |
| 00857068006075 | 16 Fr. Active Venting Cryo Decompression Tube (Low Durometer) |
| 00857068006068 | 16 Fr. Active Venting Kit 5 16 Fr. Active Venting Cryo Decompression Tube 5 Active Venting Cathe |
| 00857068006051 | 16 Fr. Active Venting Cryo Decompression Tube |
| 00857068006044 | Active Venting Spray Kit 5 Active Venting Cryo Decompression Tube 5 Active Venting Catheter |
| 00857068006037 | Active Venting Cryo Decompression Tube |
| 00857068006020 | Active Venting Catheter |
| 00857068006013 | Passive Venting Catheter |
| 00857068006006 | truFreeze Console |
| 00857068006143 | Rapid AV Kit with 20 Fr CDT (5 pack) |
| 10857068006119 | Box of 5 Active Venting Catheters |
| 10857068006102 | Rapid AV Catheter, box of 5 |
| 10857068006058 | 16 Fr. Active Venting Cryo Decompression Tube Box of 5 |
| 10857068006034 | Box of 5 Active Venting Cryo Decompression Tubes |
| 10857068006027 | Box of 5 Active Venting Catheters |
| 10857068006010 | Box of 5 Passive Venting Catheters |
| 10857068006072 | 16 Fr Active Venting Cryo Decompression Tube (Low Durometer), Box of 5 |
Trademark Results [truFreeze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUFREEZE 77813346 3891062 Live/Registered |
CSA MEDICAL, INC. 2009-08-26 |
 TRUFREEZE 77813330 3891061 Live/Registered |
CSA MEDICAL, INC. 2009-08-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.