FDA.reportPublic FDA data

MiniACE

Primary DI
00842071136666
Brand
MiniACE
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ACE-1010
Catalog number
ACE-1010
Device description
MiniACE Low Profile Antegrade Continence Enema Button - 10F x 1.0 cm, MDR
Published
2024-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXDIrrigator, Ostomy
KNTTubes, Gastrointestinal (And Accessories)
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXDIrrigator, OstomyGastroenterology, Urology2
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180026000Bowel Management Device, Bowel Management Irrigation SetApplied Medical Technology, Inc.2018-06-01KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071136666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071136666008420711366668420711366660842071136666

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0

Contacts#

Phone, Email table
PhoneEmail
(440)717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-1221E2-1221, 2-12212024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-1221-ISOSAFE2-1221-ISOSAF, 2-1221-ISOSAF2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-2421E2-2421, 2-24212024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-2421-ISOSAFE2-2421-ISOSAF, 2-2421-ISOSAF2024-06-26
00842071136642MiniACEACE-1008ACE-10082024-08-30
00842071136659MiniACEACE-1008-IACE-1008-I2024-08-30
00842071136673MiniACEACE-10100ACE-101002024-08-30
00842071136680MiniACEACE-10100-IACE-10100-I2024-08-30
00842071136697MiniACEACE-1010-IACE-1010-I2024-08-30
00842071136703MiniACEACE-1012ACE-10122024-08-30
00842071136710MiniACEACE-1012-IACE-1012-I2024-08-30
00842071136727MiniACEACE-1015ACE-10152024-08-30
00842071136734MiniACEACE-1015-IACE-1015-I2024-08-30
00842071136741MiniACEACE-1017ACE-10172024-08-30
00842071136758MiniACEACE-1017-IACE-1017-I2024-08-30
00842071136765MiniACEACE-1020ACE-10202024-08-30
00842071136772MiniACEACE-1020-IACE-1020-I2024-08-30
00842071136789MiniACEACE-1023ACE-10232024-08-30
00842071136796MiniACEACE-1023-IACE-1023-I2024-08-30
00842071136802MiniACEACE-1025ACE-10252024-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012354KangarooCardinal Health 200, LLCKNT2025-07-11
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118563MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118563MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118563MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118570MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118570MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118570MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118617MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118617MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118617MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118624MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118624MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118624MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118631MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.EXD2018-07-02
00842071118631MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02