Capsule Monarch® Gastrostomy Tube E9-C1210

GUDID 00842071103835

12FR Capsule Monarch® Gastrostomy Tube (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube

• Primary Device ID: 00842071103835
• NIH Device Record Key: d219a09a-982c-4746-8faf-3115e110ab45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capsule Monarch® Gastrostomy Tube
• Version Model Number: E9-C1210
• Catalog Number: E9-C1210
• 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: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071103835 [Primary]
GS1	00842071105983 [Package]; Package: Box (9-C1210) [2 Units]; Discontinued: 2017-03-06; Not in Commercial Distribution

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: 2016-08-31

On-Brand Devices [Capsule Monarch® Gastrostomy Tube]

• 00842071116552: 20FR Capsule Monarch Gastrostomy Tube (Boxed 1)
• 00842071116545: 18FR Capsule Monarch Gastrostomy Tube (Boxed 1)
• 00842071116521: 14FR Capsule Monarch Gastrostomy Tube (Boxed 1)
• 00842071116507: 12FR Capsule Monarch Gastrostomy Tube (Boxed 1)
• 00842071116309: 20FR Capsule Monarch Gastrostomy Tube (Enfit, Boxed)
• 00842071116293: 18FR Capsule Monarch Gastrostomy Tube (Enfit, Boxed)
• 00842071116286: 14FR Capsule Monarch Gastrostomy Tube (Enfit, Boxed)
• 00842071116279: 12FR Capsule Monarch Gastrostomy Tube (Enfit, Boxed)
• 00842071106034: 20FR Capsule Monarch Gastrostomy Tube (Pouched)
• 00842071106027: 18FR Capsule Monarch Gastrostomy Tube (Pouched)
• 00842071106003: 14FR Capsule Monarch Gastrostomy Tube (Pouched)
• 00842071103835: 12FR Capsule Monarch® Gastrostomy Tube (Pouched)