AccessGUDID - DEVICE: MiniACE™ Low Profile Antegrade Continence Enema Button (00842071118976)

GUDID

Device Identifier (DI) Information

Brand Name: MiniACE™ Low Profile Antegrade Continence Enema Button
Version or Model: ACE-1235-I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACE-1235-I
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071118976
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 3.5cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

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Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)
PIF	Gastrointestinal Tubes With Enteral Specific Connectors
EXD	Irrigator, Ostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180026	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Length: 3.5 Centimeter

Device Record Status

Public Device Record Key: 6d33042a-d7e7-4e07-8535-44b13a4577b7
Public Version Date: August 07, 2020
Public Version Number: 3
DI Record Publish Date: July 02, 2018