AccessGUDID - DEVICE: NeilMed Nasogel (00705928000995)

GUDID

Device Identifier (DI) Information

Brand Name: NeilMed Nasogel
Version or Model: Nasogel Tube
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NG-6R-96-ENU-USL
Company Name: NEILMED PHARMACEUTICALS, INC.

Primary DI Number: 00705928000995
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799295915 *Terms of Use

Device Description: Nasogel provide moisturize to hydrate and lubricate dry and irritated nasal passages caused by dry climate and indoor heat. It helps reduce nasal dryness experienced during air travel, oxygen and CPAP use, as well as dryness symptoms caused by atrophic rhinitis, post radiation therapy and sinus surgery.

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?
47679	Nasal mucosa dressing, non-antimicrobial	A material (e.g., solution, spray, gel, oil, balm) intended to be applied to nasal mucosa for one or a variety of therapeutic applications such as providing a protective barrier, hydrating the mucosa, washing/removing excessive secretions, loosening nasal encrustations, and/or reducing mucosal irritation/inflammation/oedema from environmental exposures (e.g., pet allergens, pollen), infection, or postsurgical healing, or for snoring control. It is composed of one or a combination of compounds (e.g., acids, provitamins, mannitol); it does not include an antimicrobial agent(s). It is intended for use in the home or a clinical setting. After application, this device 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: 9922afe6-d2f7-432d-a128-f07fcc42fe61
Public Version Date: July 12, 2022
Public Version Number: 1
DI Record Publish Date: July 04, 2022