AccessGUDID - DEVICE: NA (00724995000615)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Quick Connect
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QFC1760E
Company Name: STERIS CORPORATION

Primary DI Number: 00724995000615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868205779 *Terms of Use

Device Description: The Quick Connect for Fujifilm 530/580/600 Series GI Endoscopes is used with C1160E Universal Flexible Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MED	Sterilant, medical devices

FDA Premarket Submission

FDA Premarket 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
K230582	000
K232914	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c2ea618-c551-4ad8-bb83-992fb4211de1
Public Version Date: November 04, 2024
Public Version Number: 16
DI Record Publish Date: September 13, 2016