AccessGUDID - DEVICE: Torrent (00724995216849)

GUDID

Device Identifier (DI) Information

Brand Name: Torrent
Version or Model: 00711571
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711571
Company Name: US Endoscopy

Primary DI Number: 00724995216849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00724995184001

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	endoscopic irrigation/suction system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140405	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 457f8278-1caf-4e64-82b4-45b111ef25d8
Public Version Date: May 15, 2023
Public Version Number: 1
DI Record Publish Date: May 05, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
50724995216844	100	00724995216849	In Commercial Distribution	Case
10724995216846	10	00724995216849	In Commercial Distribution	Box
20724995216843	50	00724995216849	In Commercial Distribution	Carton