AccessGUDID - DEVICE: Neotech RAM Cannula® (10812594012034)

GUDID

Device Identifier (DI) Information

Brand Name: Neotech RAM Cannula®
Version or Model: Yellow - Pediatric Small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N4904
Company Name: Neotech Products LLC

Primary DI Number: 10812594012034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

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

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":	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	Cannula, Nasal, Oxygen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: f6e08bc0-8a66-4c6d-b665-1ec00dd0c24c
Public Version Date: September 21, 2023
Public Version Number: 5
DI Record Publish Date: May 19, 2021