FDA.reportPublic FDA data

AMT MiniONE Extension Set

Primary DI
00842071132477
Brand
AMT MiniONE Extension Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
8-2422-ISOSAF
Catalog number
8-2422-ISOSAF
Device description
"24"" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Box 10), MDR"
Published
2024-07-19
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
KNTTubes, Gastrointestinal (And Accessories)
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110804000
K123716000
K142989000
K971757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110804000AMT G-J TUBEApplied Medical Technology, Inc.2011-10-19KNT
K123716000AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KITApplied Medical Technology, Inc.2013-04-19KNT
K142989000Mini ONE Enteral Extension SetApplied Medical Technology, Inc.2015-01-29PIF
K971757000LOW PROFILE FEEDING SET ACCESSORYApplied Medical Technologies1997-11-07KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071132477PrimaryGS10
00842071132613Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071132477008420711324778420711324770842071132477
00842071132613008420711326138420711326130842071132613

GMDN Terms#

Term, Definition table
TermDefinition
Enteral tube extension, single-useA thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube, gastrostomy tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. 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
10
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
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
00842071136666MiniACEACE-1010ACE-10102024-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071119973MiniACE™APPLIED MEDICAL TECHNOLOGY, INC.PIF2019-09-06
00842071119973MiniACE™APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-09-06
00842071119980MiniACE™APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-09-06
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
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.KNT2018-07-02
00842071118570MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
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.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.PIF2018-07-02
00842071118631MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118648MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118648MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118655MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118655MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118662MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118662MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118679MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02