FDA.reportPublic FDA data

Y-Port Feeding Adapter

Primary DI
00842071133375
Brand
Y-Port Feeding Adapter
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E4-2012-ISOSAF
Catalog number
E4-2012-ISOSAF, 4-2012-ISOSAF
Device description
12 FR Feeding Adapter (ENFit, Pouched), MDR
Published
2024-10-04
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
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043027000MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20Applied Medical Technology, Inc.2004-12-02KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071133474PackageGS110In Commercial Distribution
00842071133375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071133474008420711334748420711334740842071133474
00842071133375008420711333758420711333750842071133375

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/non-ISO80369-standardized 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 one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

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.KNT2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
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00842071121259MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121266MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11