MiniACE Low Profile Antegrade Continence Enema Irrigation Set E2-1221-ISOSAF, 2-1221-ISOSAF

GUDID 00842071132217

12" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Caecostomy tube

• Primary Device ID: 00842071132217
• NIH Device Record Key: 0bed7c51-02e5-4882-a3c5-fcb04069ea82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniACE Low Profile Antegrade Continence Enema Irrigation Set
• Version Model Number: E2-1221-ISOSAF
• Catalog Number: E2-1221-ISOSAF, 2-1221-ISOSAF
• 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: false
• 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
• 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
• Length: 12 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071132170 [Primary]
GS1	00842071132217 [Package]; Contains: 00842071132170; Package: Box (2-1221-ISOSAF) [10 Units]; In Commercial Distribution

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [MiniACE Low Profile Antegrade Continence Enema Irrigation Set]

• 00842071132231: 24" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR
• 00842071132224: 24" Right Angle Irrigation Set - For Use with the MiniACE® Button (Pouched), MDR
• 00842071132217: 12" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR
• 00842071132200: 12" Right Angle Irrigation Set - For Use with the MiniACE® Button (Pouched), MDR