FDA.reportPublic FDA data

AMT Y-Port Accessory

Primary DI
00842071133566
Brand
AMT Y-Port Accessory
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E4-0005-ISOSAF
Catalog number
E4-0005-ISOSAF, 4-0005-ISOSAF
Device description
Dual ENFit Y-Port Accessory (Pouched), MDR
Published
2025-10-03
Public version status
New
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
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142989000Mini ONE Enteral Extension SetApplied Medical Technology, Inc.2015-01-29PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071133573PackageGS110In Commercial Distribution
00842071133566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071133573008420711335738420711335730842071133573
00842071133566008420711335668420711335660842071133566

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/ENFit linear connectorA small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at both ends intended to connect two enteral devices (e.g., enteral syringe, feeding tube, administration set) with each other; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

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
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136734MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136741MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136758MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136765MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136772MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136789MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136796MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136802MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136819MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136826MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136833MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136840MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136857MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136864MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136871MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136888MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136895MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136901MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136918MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136925MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136932MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30