AMT Mini™ Balloon Button

GUDID 00842071103231

16FR x 3.0 cm Mini Balloon Button - Low Profile Feeding Device (Tray)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071103231
• NIH Device Record Key: 865a4d13-1a72-4ae6-ac56-77ba59cd7452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Mini™ Balloon Button
• Version Model Number: E5-1630
• 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

Device Dimensions

• Catheter Gauge: 16 French
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071103231 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-02

On-Brand Devices [AMT Mini™ Balloon Button]

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• 00842071110673: 24FR x 2.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110666: 24FR x 2.3 cm Mini Balloon Button with Patient Care Kit
• 00842071110659: 24FR x 2.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110642: 24FR x 1.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110635: 24FR x 1.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110628: 20FR x 4.4 cm Mini Balloon Button with Patient Care Kit
• 00842071110611: 20FR x 4.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110604: 20FR x 3.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110598: 20FR x 3.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110581: 20FR x 2.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110574: 20FR x 2.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110567: 20FR x 2.3 cm Mini Balloon Button with Patient Care Kit
• 00842071110550: 20FR x 2.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110543: 20FR x 1.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110536: 20FR x 1.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110529: 20FR x 1.2 cm Mini Balloon Button with Patient Care Kit
• 00842071110512: 20FR x 1.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110505: 18FR x 6.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110499: 18FR x 5.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110482: 18FR x 4.4 cm Mini Balloon Button with Patient Care Kit
• 00842071110475: 18FR x 4.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110468: 18FR x 3.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110451: 18FR x 3.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110444: 18FR x 2.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110437: 18FR x 2.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110420: 18FR x 2.3 cm Mini Balloon Button with Patient Care Kit
• 00842071110413: 18FR x 2.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110406: 18FR x 1.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110390: 18FR x 1.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110383: 18FR x 1.2 cm Mini Balloon Button with Patient Care Kit
• 00842071110376: 18FR x 1.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110369: 16FR x 4.4 cm Mini Balloon Button with Patient Care Kit
• 00842071110352: 16FR x 4.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110345: 16FR x 3.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110338: 16FR x 3.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110321: 16FR x 2.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110314: 16FR x 2.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110307: 16FR x 2.3 cm Mini Balloon Button with Patient Care Kit
• 00842071110291: 16FR x 2.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110284: 16FR x 1.7 cm Mini Balloon Button with Patient Care Kit
• 00842071110277: 16FR x 1.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110260: 16FR x 1.2 cm Mini Balloon Button with Patient Care Kit
• 00842071110253: 16FR x 1.0 cm Mini Balloon Button with Patient Care Kit
• 00842071110246: 14FR x 6.5 cm Mini Balloon Button with Patient Care Kit
• 00842071110239: 14FR x 6.0 cm Mini Balloon Button with Patient Care Kit