truFreeze ACCCC3CDT05
GUDID 10724995199200
20 FR CryoDecompression Tube (CDT) Active Venting is used with the truFreeze Spray Cryotherapy System.
US Endoscopy
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 10724995199200 |
| NIH Device Record Key | ebc78408-8117-4cb5-9064-392cbe59830a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | truFreeze |
| Version Model Number | ACCCC3CDT05 |
| Catalog Number | ACCCC3CDT05 |
| Company DUNS | 627879687 |
| Company Name | US Endoscopy |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995199203 [Primary] |
| GS1 | 00857068006037 [Previous] |
| GS1 | 10724995199200 [Package] Contains: 00724995199203 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| GEH | UNIT, CRYOSURGICAL, ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-12 |
| Device Publish Date | 2022-05-04 |
On-Brand Devices [truFreeze]
| 10724995199231 | The Vortex Spray Kit is for use as a cryosurgical tool to ablate benign lesions (e.g., Barrett's |
| 10724995199330 | Rapid AV Active Venting Cathether is used with the truFreeze Spray Cryotherapy System. |
| 10724995199323 | Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introd |
| 10724995199286 | truFreeze Aire PV Passive Venting Catheter Kit includes 7 Fr Catheter, Straight Spray Catheter |
| 10724995199224 | Rapid AV Catheter Kit with 20 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introduc |
| 10724995199217 | 16 FR CryoDecompression Tube (CDT) - Low Durometer is used with the truFreeze Spray Cryotherapy |
| 10724995199200 | 20 FR CryoDecompression Tube (CDT) Active Venting is used with the truFreeze Spray Cryotherapy |
| 00724995199296 | truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during b |
| 00724995199302 | truFreeze Spray Cryotherapy Console - Evaluation Unit |
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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