MiniACE™ ACE-1280

GUDID 00842071120030

MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 8.0cm

APPLIED MEDICAL TECHNOLOGY, INC.

Cecostomy tube

• Primary Device ID: 00842071120030
• NIH Device Record Key: 786589d0-633a-4616-aeca-abb16f34974f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniACE™
• Version Model Number: ACE-1280
• Catalog Number: ACE-1280
• 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: 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
• 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: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French
• Length: 8 Centimeter
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071120030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180026

FDA Product Code

• EXD: Irrigator, Ostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-06

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• 00842071120139: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 9.0cm
• 00842071120122: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 8.0cm
• 00842071120115: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 7.0cm
• 00842071120108: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 6.5cm
• 00842071120092: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 6.0cm
• 00842071120085: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 5.5cm
• 00842071120078: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 5.0cm
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• 00842071120054: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 10.0cm
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• 00842071120030: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 8.0cm
• 00842071120023: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 7.0cm
• 00842071120016: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 6.5cm
• 00842071120009: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 6.0cm
• 00842071119997: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 5.5cm
• 00842071119980: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 5.0cm
• 00842071119973: MiniACE™ Low Profile Antegrade Continence Enema Button - 12F x 4.4cm