AccessGUDID - DEVICE: NeilMed Sinus Rinse Refill Box (00705928052000)

GUDID

Device Identifier (DI) Information

Brand Name: NeilMed Sinus Rinse Refill Box
Version or Model: Isotonic, 50ct Packets/Sachets
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEILMED PHARMACEUTICALS, INC.

Primary DI Number: 00705928052000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799295915 *Terms of Use

Device Description: Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle assembly (bottle, cap and tube that is affixed to the cap). The packets/sachets contain a defined ratio of sodium chloride and sodium bicarbonate that provides a pH balanced isotonic, solution the resulting saline solution is squirted through a bottle assembly designed at NeilMed Products, Inc. The regular Isotonic Sinus Rinse packets/sachets have salt concentration with a tonicity close to that of plasma or serum. The Isotonic Sinus Rinse Kit comes with a 240mL bottle premixed Packets/sachets containing a mixture of sodium chloride and sodium bicarbonate. This produces 0.9 % saline solution on mixing one packet with 240mL of water. The packets/sachets also come in an individual box

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):	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
KCJ	Applicator, Ent

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: 7ae79fcc-d4bf-46c1-ac63-c50f25f3e036
Public Version Date: March 10, 2023
Public Version Number: 1
DI Record Publish Date: March 02, 2023