AMT Balloon G-Tube 7-1810-I

GUDID 00842071118518

18FR Balloon G-Tube with ENFit® Port (Boxed 1)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube

• Primary Device ID: 00842071118518
• NIH Device Record Key: f937fa3c-6dd2-49a9-91df-b6c99dbc1110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Balloon G-Tube
• Version Model Number: 7-1810-I
• Catalog Number: 7-1810-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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071118518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971434

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: 3
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-03-30

On-Brand Devices [AMT Balloon G-Tube]

• 00842071118532: 24FR Balloon G-Tube with ENFit® Port (Boxed 1)
• 00842071118525: 20FR Balloon G-Tube with ENFit® Port (Boxed 1)
• 00842071118518: 18FR Balloon G-Tube with ENFit® Port (Boxed 1)
• 00842071118501: 16FR Balloon G-Tube with ENFit® Port (Boxed 1)
• 00842071118495: 14FR Balloon G-Tube with ENFit® Port (Boxed 1)
• 00842071118488: 12FR Balloon G-Tube with ENFit® Port (Boxed 1)
• 00842071116446: 24FR Balloon G-Tube (Boxed 1)
• 00842071116439: 20FR Balloon G-Tube (Boxed 1)
• 00842071116422: 18FR Balloon G-Tube (Boxed 1)
• 00842071116415: 16FR Balloon G-Tube (Boxed 1)
• 00842071116408: 14FR Balloon G-Tube (Boxed 1)
• 00842071116392: 12FR Balloon G-Tube (Boxed 1)
• 00842071116262: 24FR Balloon G-Tube (Hybrid, Boxed)
• 00842071116255: 20FR Balloon G-Tube (Hybrid, Boxed)
• 00842071116248: 18FR Balloon G-Tube (Hybrid, Boxed)
• 00842071116231: 16FR Balloon G-Tube (Hybrid, Boxed)
• 00842071116224: 14FR Balloon G-Tube (Hybrid, Boxed)
• 00842071116217: 12FR Balloon G-Tube (Hybrid, Boxed)
• 00842071114817: 20FR Balloon G-Tube (ISOSAF, Boxed 2)
• 00842071114800: 18FR Balloon G-Tube (ISOSAF, Boxed 2)
• 00842071114794: 16FR Balloon G-Tube (ISOSAF, Boxed 2)
• 00842071114787: 14FR Balloon G-Tube (ISOSAF, Boxed 2)
• 00842071114770: 12FR Balloon G-Tube (ISOSAF, Boxed 2)
• 00842071106218: 24FR Balloon G-Tube (Pouched)
• 00842071106195: 20FR Balloon G-Tube (Pouched)
• 00842071106171: 18FR Balloon G-Tube (Pouched)
• 00842071106157: 16FR Balloon G-Tube (Pouched)
• 00842071103668: 14FR Balloon G-Tube (Pouched)
• 00842071103637: 12FR Balloon G-Tube (Pouched)
• 00842071131241: 14F Balloon G-Tube - 8 cm tail length (Boxed)
• 00842071131234: 14F Balloon G-Tube - 6 cm tail length (Boxed)
• 00842071131227: 14F Balloon G-Tube - 4 cm tail length (Boxed)