Capsule Monarch® G-Tube 9-C1810

GUDID 00842071133627

18FR Capsule Monarch G-Tube, MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube

• Primary Device ID: 00842071133627
• NIH Device Record Key: e6875b46-ff18-4f92-ace8-3a7963d8b137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capsule Monarch® G-Tube
• Version Model Number: 9-C1810
• Catalog Number: 9-C1810
• 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: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071133627 [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 Monarch® G-Tube]

• 00842071133771: 20FR Capsule Monarch G-Tube with Guidewire (Enfit), MDR
• 00842071133764: 20FR Capsule Monarch G-Tube with Guidewire, MDR
• 00842071133757: 18FR Capsule Monarch G-Tube with Guidewire (Enfit), MDR
• 00842071133740: 18FR Capsule Monarch G-Tube with Guidewire, MDR
• 00842071133733: 14FR Capsule Monarch G-Tube with Guidewire (Enfit), MDR
• 00842071133726: 14FR Capsule Monarch G-Tube with Guidewire, MDR
• 00842071133719: 12FR Capsule Monarch G-Tube with Guidewire (Enfit), MDR
• 00842071133702: 12FR Capsule Monarch G-Tube with Guidewire, MDR
• 00842071133658: 20FR Capsule Monarch G-Tube (Enfit), MDR
• 00842071133641: 20FR Capsule Monarch G-Tube, MDR
• 00842071133634: 18FR Capsule Monarch G-Tube (Enfit), MDR
• 00842071133627: 18FR Capsule Monarch G-Tube, MDR
• 00842071133610: 14FR Capsule Monarch G-Tube (Enfit), MDR
• 00842071133603: 14FR Capsule Monarch G-Tube, MDR
• 00842071133597: 12FR Capsule Monarch G-Tube (Enfit), MDR
• 00842071133580: 12FR Capsule Monarch G-Tube, MDR