MiniACE™ Low Profile Antegrade Continence Enema Button ACE-1465-I

GUDID 00842071119157

MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 14F x 6.5cm

APPLIED MEDICAL TECHNOLOGY, INC.

Cecostomy tube

• Primary Device ID: 00842071119157
• NIH Device Record Key: cf37d188-16b7-4919-bb3d-8c1e7fcd5f06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniACE™ Low Profile Antegrade Continence Enema Button
• Version Model Number: ACE-1465-I
• Catalog Number: ACE-1465-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: 6.5 Centimeter
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter
• Catheter Gauge: 14 French
• Length: 6.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071119157 [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

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