AccessGUDID - DEVICE: Scope Assist Flushing Sink (SAFS) (FLUSHINGSINKMODELS6)

GUDID

Device Identifier (DI) Information

Brand Name: Scope Assist Flushing Sink (SAFS)
Version or Model: S6
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Wassenburg Medical, Inc.

Primary DI Number: FLUSHINGSINKMODELS6
Issuing Agency: HIBCC
Commercial Distribution End Date: July 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 118762097 *Terms of Use

Device Description: A device use to flush endoscopes.

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?
66649	Endoscope washer-disinfector (chemical)	An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEB	Accessories, Cleaning, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162120	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
Special Storage Condition, Specify: Keep dry
Handling Environment Temperature: between 0 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Do not fork lift
Special Storage Condition, Specify: Fraglie

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f441c04d-fbfc-4885-96d2-952ec2173184
Public Version Date: March 19, 2025
Public Version Number: 5
DI Record Publish Date: May 16, 2017