Device
EDKN-004005/004006/004013/004014
Manufacturer
Changzhou Endoclean Medical Device Co.,Ltd
Changzhou Endoclean Medical Device Co.,Ltd
Model: EDKN-004005/004006/004013/004014
DI: 06973141950319
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
186d1de3-673f-4c4f-af21-cced5a192810
Distribution Status:
In Commercial Distribution
DUNS Number:
705006876
Device Count:
1
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Device ID:
06973141950319
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60760
Name: Endoscope channel support kit
Definition:
A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.
FDA Product Codes
ODC
Endoscope Channel Accessory
Premarket Submissions
Submission Number:
K221331
Supplement Number:
000