AccessGUDID - DEVICE: Acu-SinQ (00724995167745)

GUDID

Device Identifier (DI) Information

Brand Name: Acu-SinQ
Version or Model: Acu-SinQ Complete
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AQSCOMP
Company Name: Corporation Steris Canada

Primary DI Number: 00724995167745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202659140 *Terms of Use

Device Description: The Acu-SinQ Complete Endoscope Cleaning Aid System is designed to provide support for automated leak testing, dosing, temperature monitoring, channel flushing, rinsing, and process documentation.

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?
66797	Surgical instrument washer/disinfector (chemical/thermal)	An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite.	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: add77ea6-7bc8-400e-b913-c0ce00af6263
Public Version Date: November 21, 2023
Public Version Number: 6
DI Record Publish Date: February 28, 2019