MiniACE Low Profile Antegrade Continence Enema Irrigation Set E2-2421, 2-2421

GUDID 00842071132224

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

APPLIED MEDICAL TECHNOLOGY, INC.

Caecostomy tube
Primary Device ID00842071132224
NIH Device Record Keyd901aa3d-8e3e-472a-b7e2-ccca68e2b124
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniACE Low Profile Antegrade Continence Enema Irrigation Set
Version Model NumberE2-2421
Catalog NumberE2-2421, 2-2421
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net

Device Dimensions

Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch
Length24 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071132187 [Primary]
GS100842071132224 [Package]
Contains: 00842071132187
Package: Box (2-2421) [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

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

0084207113223124" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR
0084207113222424" Right Angle Irrigation Set - For Use with the MiniACE® Button (Pouched), MDR
0084207113221712" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR
0084207113220012" Right Angle Irrigation Set - For Use with the MiniACE® Button (Pouched), MDR

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