AMT MiniONE Extension Set

Basic Information

• Brand Name: AMT MiniONE Extension Set
• Primary DI: 00842071132385
• Version / Model: 8-1211
• Catalog Number: 8-1211
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-07-19
• Public Version: 2
• Public Version Date: 2024-12-23
• Public Version Status: Update
• Public Device Record Key: 137b1bb3-873e-478d-a479-29b3276c8c83

Device Description

12" MiniONE Bolus Feeding Set with Single Port (Box 10), MDR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00842071132521	GS1
Primary	00842071132385	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110804	000
K123716	000
K971757	000

Device Sizes

Type	Value	Unit	Text
Length	12	Inch