N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333241774
• Version / Model: 100242P
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-03-13
• Public Version: 4
• Public Version Date: 2018-10-08
• Public Version Status: Update
• Public Device Record Key: a2ba83e8-1294-40ea-b9d9-567ee2bf2485
• Distribution End Date: 2018-06-21

Device Description

WATERJET CONN, DISP, SINGLE, 10/PKG

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: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60758	Endoscopic procedure air/water valve, single-use	A sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333241774	GS1
Unit of Use	14961333241771	GS1

Premarket Submissions

Submission Number	Supplement Number
K092429	000