AMT Capsule Dome G-Tube 9-CG2020-I

GUDID 00842071116354

20FR Capsule Dome G-Tube with Guidewire (Enfit, Boxed)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube

• Primary Device ID: 00842071116354
• NIH Device Record Key: 4881d008-a500-47d5-b9e6-7bcaefc9b0bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Capsule Dome G-Tube
• Version Model Number: 9-CG2020-I
• Catalog Number: 9-CG2020-I
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Catheter Gauge: 20 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071116354 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-03-06

On-Brand Devices [AMT Capsule Dome G-Tube]

• 00842071116668: 24FR Capsule Dome G-Tube with Guidewire (Boxed 1)
• 00842071116651: 20FR Capsule Dome G-Tube with Guidewire (Boxed 1)
• 00842071116583: 24FR Capsule Dome G-Tube (Boxed 1)
• 00842071116576: 20FR Capsule Dome G-Tube (Boxed 1)
• 00842071116385: 24FR Capsule Dome G-Tube (Enfit, Boxed)
• 00842071116378: 20FR Capsule Dome G-Tube (Enfit, Boxed)
• 00842071116361: 24FR Capsule Dome G-Tube with Guidewire (Enfit, Boxed)
• 00842071116354: 20FR Capsule Dome G-Tube with Guidewire (Enfit, Boxed)
• 00842071111694: 24FR Capsule Dome G-Tube with Guidewire (Boxed)
• 00842071111687: 20FR Capsule Dome G-Tube with Guidewire (Boxed)
• 00842071109288: 24 Fr Capsule Dome G-Tube (Sterile, Pouched)
• 00842071111663: 20 Fr Capsule Dome G-Tube (Sterile, Pouched)