truFreeze 2000184

GUDID 10724995199330

Rapid AV Active Venting Cathether is used with the truFreeze Spray Cryotherapy System.

US Endoscopy

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 10724995199330
• NIH Device Record Key: 919fcd7e-e976-4f3e-8d8e-409d24473e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: truFreeze
• Version Model Number: 2000184
• Catalog Number: 2000184
• 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
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• 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
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

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	00724995199333 [Primary]
GS1	00857068006105 [Previous]
GS1	10724995199330 [Package]; Contains: 00724995199333; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113021
• Premarket Notification: K171626

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