Torrent

Basic Information

• Brand Name: Torrent
• Primary DI: 00724995216849
• Version / Model: 00711571
• Catalog Number: 00711571
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-05
• Public Version: 1
• Public Version Date: 2023-05-15
• Public Version Status: New
• Public Device Record Key: 457f8278-1caf-4e64-82b4-45b111ef25d8

Device Description

The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile water during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	endoscopic irrigation/suction system	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995216844	GS1	Case	100	In Commercial Distribution
Primary	00724995216849	GS1
Package	10724995216846	GS1	Box	10	In Commercial Distribution
Package	20724995216843	GS1	Carton	50	In Commercial Distribution
Previous	00724995184001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140405	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry