AccessGUDID - DEVICE: 8000 Series Reusable Channel Cleaning Brush (M45381070)

GUDID

Device Identifier (DI) Information

Brand Name: 8000 Series Reusable Channel Cleaning Brush
Version or Model: 8107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8107
Company Name: Primed Instruments Inc

Primary DI Number: M45381070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070

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 device is individually packaged.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Working Length: 70cm
Device Size Text, specify: Brush Diameter: 3.0-5.0mm
Device Size Text, specify: Minimum Channel Size: 2.0mm

Device Record Status

Public Device Record Key: 081348d6-94d3-4a2f-89fb-f18db1c34133
Public Version Date: December 21, 2018
Public Version Number: 1
DI Record Publish Date: November 20, 2018