CO2 Source Tubing

GUDID 06936534332246

Zhejiang Chuangxiang Medical Technology Co., LTD.

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 06936534332246
• NIH Device Record Key: 57501290-b44c-4362-a5fc-395fb715e8bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2 Source Tubing
• Version Model Number: MD-A-TS-2100
• Company DUNS: 544434963
• Company Name: Zhejiang Chuangxiang Medical Technology 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936534332246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231471

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-01
• Device Publish Date: 2023-10-24

Devices Manufactured by Zhejiang Chuangxiang Medical Technology Co., LTD.

• 06970401812240 - Polyp Trap: 2024-08-06
• 06936534331614 - Polyp Trap: 2024-07-30 EO sterile
• 06970401816910 - Polyp Trap: 2024-07-30 EO sterile
• 06970401814039 - Polyp Trap: 2024-07-22 EO sterile
• 06936534332260 - Air/Water Bottle Tubing: 2023-12-26
• 06936534338675 - Endoscopy Irrigation Tubing: 2023-12-26
• 06936534338682 - Endoscopy Irrigation Tubing: 2023-12-26
• 06936534325439 - Single Use Urinary Guidewire: 2023-12-05