FDA.reportPublic FDA data

MiniACE

Primary DI
00842071136819
Brand
MiniACE
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ACE-1025-I
Catalog number
ACE-1025-I
Device description
MiniACE Low Profile Antegrade Continence Enema Button with ENFit® - 10F x 2.5 cm, MDR
Published
2024-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
00842071136819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071136819008420711368198420711368190842071136819

GMDN Terms#

Term, Definition table
TermDefinition
Caecostomy tubeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length2.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071153083NutraGlide Nasal Feeding TubeENFT-05055-IENFT-05055-I, NFT-05055-I2026-06-10
00842071153106NutraGlide Nasal Feeding TubeENFT-05090-IENFT-05090-I, NFT-05090-I2026-06-10
00842071153120NutraGlide Nasal Feeding TubeENFT-06055-IENFT-06055-I, NFT-06055-I2026-06-10
00842071153144AMT MiniONE Extension SetE8-2455-ISOSAFE8-2455-ISOSAF, 8-2455-ISOSAF2026-05-13
00842071147198MINI Balloon Button5-24272026-05-07
00842071147204MINI Balloon Button5-2427-I5-2427-I2026-05-07
00842071153045AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-04-28
00842071153069AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-04-28
00842071146276MINI Balloon Button5-14555-14552026-04-09
00842071146283MINI Balloon Button5-1455-I5-1455-I2026-04-09
00842071148935GEMINI Suture LoopES4-8000ES4-8000, S4-80002025-04-07
00842071151119RHAPSOESD110-S-07ESD110-S-07, SD110-S-07-101, SD110-S-07-1052026-03-25
00842071151140RHAPSOESD110-C-07ESD110-C-07, SD110-C-07-101, SD110-C-07-1052026-03-25
00842071153021AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071153038AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071150952AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-03-18
00842071150976AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-03-18
00842071152758MiniSPC ButtonSPC-2425-12SPC-2425-122026-03-18
00842071152765MiniSPC ButtonSPC-2425-24SPC-2425-242026-03-18
00842071152772MiniSPC ButtonSPC-2427-12SPC-2427-122026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
05060999351564EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351595EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351625EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351656EnteralGBUK GROUP LIMITEDPIF2025-08-20
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
05060999350017NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350048NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350079NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350109NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350130NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350161NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350192NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350222NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350253NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350284NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350314NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350345NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350376NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350451NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350482NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350512NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350543NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350574NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350604NutricareGBUK GROUP LIMITEDPIF2024-10-29