Disposable Progressive Pressure Dilators

GUDID 00813353010110

PPD Gastrointestinal Dilator 15-17mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length

Telemed Systems

Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 00813353010110
• NIH Device Record Key: 67ca478c-adba-49db-beed-e6a0ce008d57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Progressive Pressure Dilators
• Version Model Number: 1415
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813353010110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020379

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2023-07-20
• Device Publish Date: 2023-07-12

On-Brand Devices [Disposable Progressive Pressure Dilators]

• 00813353010127: PPD Gastrointestinal Dilator 18-20mm Diameter x 8cm Length Balloon Dimension 200cm Total Cathete
• 00813353010110: PPD Gastrointestinal Dilator 15-17mm Diameter x 8cm Length Balloon Dimension 200cm Total Cathete