AccessGUDID - DEVICE: Nasoneb® (00604351708006)

GUDID

Device Identifier (DI) Information

Brand Name: Nasoneb®
Version or Model: Sinus Therapy System Supply Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Monaghan Medical Corporation

Primary DI Number: 00604351708006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056332380 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
44845	Nasal irrigation set, home-use	A collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

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: 42980fbd-a809-4f0e-af79-739fdac90d2c
Public Version Date: April 27, 2022
Public Version Number: 1
DI Record Publish Date: April 19, 2022