NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995185237
• Version / Model: Quick Connect
• Catalog Number: QFC1770E
• Company Name: STERIS CORPORATION
• Labeler DUNS: 868205779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-01
• Public Version: 7
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 6b2a9d7e-bcb9-46d7-9d50-9f3342225e3a

Device Description

The Quick Connect for FUJIFILM GI Endoscopes used with C1160E Universal Flexible Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MED	Sterilant, medical devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61723	Luminal device flushing tubing set, reusable	A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995185237	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090036	000
K101409	000
K102462	000
K113520	000
K131078	000
K161683	000
K170956	000
K173256	000
K180342	000
K182827	000
K190104	000
K191343	000
K192929	000
K210737	000
K211607	000
K222615	000
K232914	000