MiniACE™ Low Profile Antegrade Continence Enema Irrigation Set

GUDID 00842071119263

12" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Box 10)

APPLIED MEDICAL TECHNOLOGY, INC.

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• Primary Device ID: 00842071119263
• NIH Device Record Key: 237fd0ca-ed4b-4777-8a6b-b40959ef576a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniACE™ Low Profile Antegrade Continence Enema Irrigation Set
• Version Model Number: 2-1221-ISOSAF
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 10
• 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
• 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: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071119225 [Unit of Use]
GS1	00842071119263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180026

FDA Product Code

• PIF: Gastrointestinal Tubes With Enteral Specific Connectors

Sterilization

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

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 Irrigation Set]

• 00842071119270: 24" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Box 10)
• 00842071119263: 12" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Box 10)
• 00842071119256: 24" Right Angle Irrigation Set - For Use with the MiniACE® Button (Box 10)
• 00842071119249: 12" Right Angle Irrigation Set - For Use with the MiniACE® Button (Box 10)