truFreeze 20-00183
GUDID 10857068006119
Box of 5 Active Venting Catheters
Csa Medical, Inc.
General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 10857068006119 |
| NIH Device Record Key | 0e01e026-e1e7-45f0-94ba-ee5933e3ba55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | truFreeze |
| Version Model Number | 20-00183 |
| Catalog Number | 20-00183 |
| 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 | |
| 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 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10857068006119 [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 |
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
[10857068006119]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2017-10-05 |
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 |
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