FDA.reportPublic FDA data

MiniACE Low Profile Antegrade Continence Enema Irrigation Set

Primary DI
00842071132194
Brand
MiniACE Low Profile Antegrade Continence Enema Irrigation Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E2-2421-ISOSAF
Catalog number
E2-2421-ISOSAF, 2-2421-ISOSAF
Device description
"24"" Right Angle Irrigation Set with ENFit® - For Use with the MiniACE® Button (Pouched), MDR"
Published
2024-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00842071132231PackageGS110In Commercial Distribution
00842071132194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071132231008420711322318420711322310842071132231
00842071132194008420711321948420711321940842071132194

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
Length24Inch

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146474MINI Balloon Button5-16275-16272026-10-22
00842071146481MINI Balloon Button5-1627-I5-1627-I2026-10-22
00842071146498MINI Balloon Button5-16305-16302026-10-22
00842071146504MINI Balloon Button5-1630-I5-1630-I2026-10-22
00842071146535MINI Balloon Button5-16405-16402026-10-22
00842071146542MINI Balloon Button5-1640-I5-1640-I2026-10-22
00842071147075MINI Balloon Button5-20445-20442026-10-22
00842071147082MINI Balloon Button5-2044-I5-2044-I2026-10-22
00842071147259MINI Balloon Button5-24405-24402026-10-22
00842071147266MINI Balloon Button5-2440-I5-2440-I2026-10-22
00842071146337MINI Balloon Button5-16105-16102026-10-20
00842071146344MINI Balloon Button5-1610-I5-1610-I2026-10-20
00842071146375MINI Balloon Button5-16155-16152026-10-20
00842071146382MINI Balloon Button5-1615-I5-1615-I2026-10-20
00842071146795MINI Balloon Button5-18445-18442026-10-20
00842071146801MINI Balloon Button5-1844-I5-1844-I2026-10-20
00842071147136MINI Balloon Button5-24205-24202026-10-20
00842071147143MINI Balloon Button5-2420-I5-2420-I2026-10-20
00842071147150MINI Balloon Button5-24235-24232026-10-20
00842071147167MINI Balloon Button5-2423-I5-2423-I2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071146474MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146481MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
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00842071146504MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
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00842071147075MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147082MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147259MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147266MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
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00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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00842071146337MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
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