truFreeze 2000360

GUDID 10724995199231

The Vortex Spray Kit is for use as a cryosurgical tool to ablate benign lesions (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.

US Endoscopy

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 10724995199231
• NIH Device Record Key: e7befef8-ea87-4884-9a3e-c2de2b5b3652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: truFreeze
• Version Model Number: 2000360
• Catalog Number: 2000360
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995199234 [Primary]
GS1	10724995199231 [Package]; Contains: 00724995199234; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201183

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: 2021-12-27
• Device Publish Date: 2021-12-17

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