AMT Mini™ Balloon Button 5-2010-I

GUDID 00842071124014

20FR x 1.0 cm Mini Balloon Button with Patient Care Kit (ENFit)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071124014
• NIH Device Record Key: e3f41a52-a345-44f1-bb82-01dbfd54a6bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Mini™ Balloon Button
• Version Model Number: 5-2010-I
• Catalog Number: 5-2010-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
• 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
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter
• Catheter Gauge: 20 French
• Length: 1 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071124014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945618

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: 2024-04-26
• Device Publish Date: 2024-04-18

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• 00842071110536: 20FR x 1.5 cm Mini Balloon Button with Patient Care Kit
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