Disposable Duralon Occlusion Balloon - 2 Lumen

GUDID 00813353010165

Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr Shaft Size x 200cm Catheter Length Proximal Injection Port

Telemed Systems

ERCP catheter, balloon, non-electrical, stone-retrieval

• Primary Device ID: 00813353010165
• NIH Device Record Key: 28abeecb-7f52-4695-a980-10e4cf0043c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Duralon Occlusion Balloon - 2 Lumen
• Version Model Number: 1720
• Company DUNS: 017939239
• Company Name: Telemed Systems
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813353010165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013737

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

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: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [Disposable Duralon Occlusion Balloon - 2 Lumen]

• 00813353010172: Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr S
• 00813353010165: Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr S
• 00813353010158: Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.5mm, 16.5mm, 20.0mm 7fr Shaft Si
• 00813353010141: Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.5mm, 16.5mm, 20.0mm 7fr Shaft Si