FDA.reportPublic FDA data

AMT Mini Extension Set

Primary DI
00842071140069
Brand
AMT Mini Extension Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E6-1222-ISOSAF
Catalog number
E6-1222-ISOSAF, 6-1222-ISOSAF
Device description
"12"" Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR"
Published
2024-07-26
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
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
K945618000

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
K945618000GASTROINTESTINAL TUBES & ACCESSORIESApplied Medical Technologies1995-10-12KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071144784PackageGS110In Commercial Distribution
00842071140069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071144784008420711447848420711447840842071144784
00842071140069008420711400698420711400690842071140069

GMDN Terms#

Term, Definition table
TermDefinition
Enteral tube extensionA thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric 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
Length12Inch

Sterilization Methods#

Method table
Method

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
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