AccessGUDID - DEVICE: AMT MiniONE Extension Set (00842071132934)

GUDID

Device Identifier (DI) Information

Brand Name: AMT MiniONE Extension Set
Version or Model: E8-0211-ISOSAF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E8-0211-ISOSAF, 8-0211-ISOSAF
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071132934
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: 2" MiniONE Medication Set with ENFit ® and Cap (Pouched), MDR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62256	Enteral tube extension, single-use	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)
PIF	Gastrointestinal Tubes With Enteral Specific Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110804	000
K123716	000
K142989	000
K971757	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Inch

Device Record Status

Public Device Record Key: 1c4026f7-a9af-46e8-9b80-1482b8b56115
Public Version Date: December 23, 2024
Public Version Number: 2
DI Record Publish Date: July 19, 2024