FDA.reportPublic FDA data

AMT MiniONE Extension Set

Primary DI
00842071153038
Brand
AMT MiniONE Extension Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E8-1255-ISOSAF
Catalog number
E8-1255-ISOSAF, 8-1255-ISOSAF
Device description
12" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K110804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110804000AMT G-J TUBEApplied Medical Technology, Inc.2011-10-19KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071153038PackageGS110In Commercial Distribution
00842071153021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071153038008420711530388420711530380842071153038
00842071153021008420711530218420711530210842071153021

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
Length12Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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