MiniACE™ Low Profile Antegrade Continence Enema Irrigation Set

Basic Information

• Brand Name: MiniACE™ Low Profile Antegrade Continence Enema Irrigation Set
• Primary DI: 00842071119263
• Version / Model: 2-1221-ISOSAF
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-07-02
• Public Version: 3
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: 237fd0ca-ed4b-4777-8a6b-b40959ef576a

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	876.5980	2
EXD	Irrigator, Ostomy	Gastroenterology, Urology	876.5895	2
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62494	Caecostomy tube	A sterile, thin, soft, hollow tube intended to be percutaneously placed and maintained in the caecum, following caecostomy, to permit instillation of fluids for colonic irrigation and evacuation of lower bowel contents through the anus, as an aid in the management of faecal incontinence. Also known as a C-tube, it is made of synthetic polymer materials and is curled at the distal end for retention in the colon; it contains a proximal port at the caecostoma to allow flushing by the user. Disposable devices to assist tube introduction/function (e.g., cannula, drainage catheter) may be included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842071119263	GS1
Unit of Use	00842071119225	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180026	000

Device Sizes

Type	Value	Unit	Text
Length	12	Inch