MINI Balloon Button 5-1417-I

GUDID 00842071146085

14FR x 1.7 cm MINI Balloon Button Kit (ENFit), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071146085
• NIH Device Record Key: d984b319-be73-4953-ab98-e0e6a7452b66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINI Balloon Button
• Version Model Number: 5-1417-I
• Catalog Number: 5-1417-I
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• 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

• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French
• Length: 1.7 Centimeter
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071146085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161413

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: 2025-06-09
• Device Publish Date: 2025-05-30

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• 00842071145767: 12FR x 0.8 cm MINI Balloon Button Kit (ENFit), MDR
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