FDA.reportPublic FDA data

AMT MiniONE Extension Set

Primary DI
00842071132330
Brand
AMT MiniONE Extension Set
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E8-2422-ISOSAF
Catalog number
E8-2422-ISOSAF, 8-2422-ISOSAF
Device description
"24"" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), 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
00842071144913PackageGS110In Commercial Distribution
00842071132330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071144913008420711449138420711449130842071144913
00842071132330008420711323308420711323300842071132330

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
Length24Inch

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
00842071153083NutraGlide Nasal Feeding TubeENFT-05055-IENFT-05055-I, NFT-05055-I2026-06-10
00842071153106NutraGlide Nasal Feeding TubeENFT-05090-IENFT-05090-I, NFT-05090-I2026-06-10
00842071153120NutraGlide Nasal Feeding TubeENFT-06055-IENFT-06055-I, NFT-06055-I2026-06-10
00842071153144AMT MiniONE Extension SetE8-2455-ISOSAFE8-2455-ISOSAF, 8-2455-ISOSAF2026-05-13
00842071147198MINI Balloon Button5-24272026-05-07
00842071147204MINI Balloon Button5-2427-I5-2427-I2026-05-07
00842071153045AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-04-28
00842071153069AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-04-28
00842071146276MINI Balloon Button5-14555-14552026-04-09
00842071146283MINI Balloon Button5-1455-I5-1455-I2026-04-09
00842071148935GEMINI Suture LoopES4-8000ES4-8000, S4-80002025-04-07
00842071151119RHAPSOESD110-S-07ESD110-S-07, SD110-S-07-101, SD110-S-07-1052026-03-25
00842071151140RHAPSOESD110-C-07ESD110-C-07, SD110-C-07-101, SD110-C-07-1052026-03-25
00842071153021AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071153038AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071150952AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-03-18
00842071150976AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-03-18
00842071152758MiniSPC ButtonSPC-2425-12SPC-2425-122026-03-18
00842071152765MiniSPC ButtonSPC-2425-24SPC-2425-242026-03-18
00842071152772MiniSPC ButtonSPC-2427-12SPC-2427-122026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
05060999351564EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351595EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351625EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351656EnteralGBUK GROUP LIMITEDPIF2025-08-20
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
05060999350017NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350048NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350079NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350109NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350130NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350161NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350192NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350222NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350253NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350284NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350314NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350345NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350376NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350451NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350482NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350512NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350543NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350574NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350604NutricareGBUK GROUP LIMITEDPIF2024-10-29