Neotech RAM Cannula®

Basic Information

• Brand Name: Neotech RAM Cannula®
• Primary DI: 10812594011297
• Version / Model: Blue - New-Born
• Catalog Number: N4902
• Company Name: Neotech Products LLC
• Labeler DUNS: 198013435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-05-19
• Public Version: 5
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: c7a8bca7-5bb4-474a-8494-259f1da719f8

Device Description

"The Neotech RAM Cannula is intended to be used for preterm and term neonates, infants, and pediatric patients who require supplemental oxygen, respiratory support or assistance in breathing in an ambulatory, hospital or institutional environment. It is used to provide oxygen with the following methods: 1. Heated or unheated, humidified low flow oxygen. 2. Heated, humidified high flow oxygen."

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
CAT	Cannula, Nasal, Oxygen	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". 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	00812594011290	GS1
Primary	10812594011297	GS1