MiniACE™ Low Profile Antegrade Continence Enema Button ACE-1480-I

GUDID 00842071119171

MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 8.0cm

APPLIED MEDICAL TECHNOLOGY, INC.

Cecostomy tube

• Primary Device ID: 00842071119171
• NIH Device Record Key: 396676a4-28d6-4484-ad4b-676992480eff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniACE™ Low Profile Antegrade Continence Enema Button
• Version Model Number: ACE-1480-I
• Catalog Number: ACE-1480-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: 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

• Length: 8 Centimeter
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter
• Catheter Gauge: 14 French
• Length: 8 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071119171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180026

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: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-07-02

On-Brand Devices [MiniACE™ Low Profile Antegrade Continence Enema Button]

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• 00842071119188: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 9.0cm
• 00842071119171: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 8.0cm
• 00842071119164: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 7.0cm
• 00842071119157: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.5cm
• 00842071119140: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.0cm
• 00842071119133: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 5.5cm
• 00842071119126: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 5.0cm
• 00842071119119: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 4.4cm
• 00842071119102: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 4.0cm
• 00842071119096: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.5cm
• 00842071119089: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 3.0cm
• 00842071119072: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.7cm
• 00842071119065: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.5cm
• 00842071119058: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.3cm
• 00842071119041: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 2.0cm
• 00842071119034: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.7cm
• 00842071119027: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.5cm
• 00842071119010: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.2cm
• 00842071119003: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 1.0cm
• 00842071118990: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 0.8cm
• 00842071118983: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 4.0cm
• 00842071118976: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 3.5cm
• 00842071118969: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 3.0cm
• 00842071118952: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.7cm
• 00842071118945: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.5cm
• 00842071118938: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.3cm
• 00842071118921: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.0cm
• 00842071118914: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.7cm
• 00842071118907: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.5cm
• 00842071118891: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.2cm
• 00842071118884: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 1.0cm
• 00842071118877: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 0.8cm
• 00842071118860: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 10.0cm
• 00842071118853: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 9.0cm
• 00842071118846: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 8.0cm
• 00842071118839: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 7.0cm
• 00842071118822: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 6.5cm
• 00842071118815: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 6.0cm
• 00842071118808: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 5.5cm
• 00842071118792: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 5.0cm
• 00842071118785: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 4.4cm
• 00842071118778: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 4.0cm
• 00842071118761: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 3.5cm
• 00842071118754: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 3.0cm
• 00842071118747: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.7cm
• 00842071118730: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.5cm
• 00842071118723: MiniACE™ Low Profile Antegrade Continence Enema Button - 14F x 2.3cm
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