AccessGUDID - DEVICE: Pre-Processing Sink (PPS83S8)

GUDID

Device Identifier (DI) Information

Brand Name: Pre-Processing Sink
Version or Model: 83-S8
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Wassenburg Medical, Inc.

Primary DI Number: PPS83S8
Issuing Agency: HIBCC
Commercial Distribution End Date: August 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 118762097 *Terms of Use

Device Description: A device intended 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?
35012	Endoscope washer/disinfector	A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes, and their accessories, with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.	Obsolete	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: Do Not Forklift
Special Storage Condition, Specify: Fragile
Handling Environment Temperature: between 0 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d597d277-06fe-44fc-b2cb-b2ca3e4c1e44
Public Version Date: July 03, 2023
Public Version Number: 5
DI Record Publish Date: October 31, 2017