AccessGUDID - DEVICE: FLAEM Rhino Clear Sprint (08018294012793)

GUDID

Device Identifier (DI) Information

Brand Name: FLAEM Rhino Clear Sprint
Version or Model: P0709EM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DR12P00
Company Name: FLAEM NUOVA SPA

Primary DI Number: 08018294012793
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431208297 *Terms of Use

Device Description: Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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?
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
JPW	Pump, Nebulizer, Electrically Powered

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
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 69 and 106 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 69 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01635ed0-2d36-4ea4-8a03-0dd03e982475
Public Version Date: March 10, 2022
Public Version Number: 2
DI Record Publish Date: July 10, 2020