Model: N05524
DI: 09350855000900
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-20
Current Version: 2026-05-28
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5df5d966-a747-4982-abd9-afbbb7b31dad
Distribution Status:
In Commercial Distribution
DUNS Number:
741021943
Device Count:
12
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
09350855000900
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
09350855001099
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 66650
Name: Endoscope flushing/rinsing sink system
Definition:
An electrically-powered assembly of devices intended to be used to flush and rinse endoscopes for pre-cleaning. It is intended to be connected to hot and cold water supplies and includes a sink with conventional style taps to facilitate pre-cleaning the external portion of the endoscopes, and a series of fluid lines for flushing each endoscope channel.
FDA Product Codes
SEW
Automated Endoscope Channel Cleaner