AccessGUDID - DEVICE: 8000 Series Reusable Channel Cleaning Brush (00666416110094)

GUDID

Device Identifier (DI) Information

Brand Name: 8000 Series Reusable Channel Cleaning Brush
Version or Model: 8880
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8880
Company Name: Primed Instruments Inc

Primary DI Number: 00666416110094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Suction Well Cleaning Brush. HIBC/UPN: M45388802

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
35979	Endoscope cleaning brush, reusable	A device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Reusable Cleaning Brushes should be stored in a sterile package at room temperature in a dry clean area away from direct sunlight. Each pouch contains 25 brushes.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Brush Diameter: 11mm
Device Size Text, specify: Working Length: 5.5cm

Device Record Status

Public Device Record Key: 32f7758b-10a7-4b4d-a8e2-481af3e72165
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 23, 2017