truFreeze 2000516
GUDID 10724995199323
Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introducer, 16 Fr CryoDecompression Tube (CDT), Dual Lumen, Connector, Suction Tubing and is used with the truFreeze Spray Cryotherapy System.
US Endoscopy
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 10724995199323 |
| NIH Device Record Key | 1fa359e3-3918-465e-b579-176f2cec5a90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | truFreeze |
| Version Model Number | 2000516 |
| Catalog Number | 2000516 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00724995199326 [Primary] |
| GS1 | 00857068006082 [Previous] |
| GS1 | 10724995199323 [Package] Contains: 00724995199326 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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