Capsule Dome G-Tube 9-C2020-I

GUDID 00842071133672

20FR Capsule Dome G-Tube (Enfit), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube

• Primary Device ID: 00842071133672
• NIH Device Record Key: f38b96a7-9970-43d2-922d-d89fa9ffcd0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capsule Dome G-Tube
• Version Model Number: 9-C2020-I
• Catalog Number: 9-C2020-I
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Dimensions

• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071133672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043027

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: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [Capsule Dome G-Tube]

• 00842071133818: 24FR Capsule Dome G-Tube with Guidewire (Enfit), MDR
• 00842071133801: 24FR Capsule Dome G-Tube with Guidewire, MDR
• 00842071133795: 20FR Capsule Dome G-Tube with Guidewire (Enfit), MDR
• 00842071133788: 20FR Capsule Dome G-Tube with Guidewire, MDR
• 00842071133696: 24FR Capsule Dome G-Tube (Enfit), MDR
• 00842071133689: 24FR Capsule Dome G-Tube, MDR
• 00842071133672: 20FR Capsule Dome G-Tube (Enfit), MDR
• 00842071133665: 20FR Capsule Dome G-Tube, MDR