Device
24" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
Manufacturer
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
Model: E8-2455-ISOSAF
Catalog: E8-2455-ISOSAF, 8-2455-ISOSAF
DI: 00842071153144
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
24" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bdde3f0e-0216-465a-8486-010d7fcc3247
Distribution Status:
In Commercial Distribution
DUNS Number:
038101861
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
00842071153151
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00842071153144
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00842071153144
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 62256
Name: Enteral tube extension, single-use
Definition:
A 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.
FDA Product Codes
KNT
Tubes, Gastrointestinal (And Accessories)
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
Premarket Submissions
Item #1 - Submission Number:
K110804
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K123716
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K142989
Item #3 - Supplement Number:
000
Item #4 - Submission Number:
K971757
Item #4 - Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Inch
Device Size - Size - @attributes - Value:
24
Device Size - Size Type:
Length