AccessGUDID - DEVICE: NA (00724995167776)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 7117161FKN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7117185FKN
Company Name: Corporation Steris Canada

Primary DI Number: 00724995167776
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 202659140 *Terms of Use

Device Description: The Fujinon Leak Test Adapter is used with the Acu-sinQ Complete Endoscope Cleaning Aid System.

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?
38460	Invasive medical device leak tester, mechanical	A hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEB	Accessories, cleaning, for endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181865	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: 8ced8cee-0772-418e-bab1-371899063c32
Public Version Date: August 09, 2021
Public Version Number: 6
DI Record Publish Date: February 28, 2019