MiniACE

Basic Information

• Brand Name: MiniACE
• Primary DI: 00842071137298
• Version / Model: ACE-1235-I
• Catalog Number: ACE-1235-I
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: de93f745-d059-41cf-a06e-f4c6125a0e83

Device Description

MiniACE Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 3.5cm, MDR

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	876.5980	2
EXD	Irrigator, Ostomy	Gastroenterology, Urology	876.5895	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	00842071137298	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180026	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French
Length	3.5	Centimeter