Endoclean

GUDID 00697314195036

Changzhou Endoclean Medical Device Co.,Ltd

Endoscope channel support kit

• Primary Device ID: 00697314195036
• NIH Device Record Key: 65996e65-8d88-4751-a5b0-94e03468a7cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoclean
• Version Model Number: EDKN-004006/004007/004008
• Company DUNS: 705006876
• Company Name: Changzhou Endoclean Medical Device Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697314195036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232244

FDA Product Code

• ODC: Endoscope Channel Accessory

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

On-Brand Devices [Endoclean]

• 06973141950043: EDKN-004002/004006/004007/004008
• 00697314195036: EDKN-004006/004007/004008