AccessGUDID - DEVICE: Montesol (00744229440758)

GUDID

Device Identifier (DI) Information

Brand Name: Montesol
Version or Model: 044F6008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PARI RESPIRATORY EQUIPMENT, INC.

Primary DI Number: 00744229440758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 804736098 *Terms of Use

Device Description: Nasal Wash, Montesol

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
41599	Nasal irrigation applicator	A dispensing device (e.g., a horn-shaped cup or holder, an irrigation bottle, or a device shaped like a tea pot with a bulbous tipped spout) used to apply a liquid treatment, usually a saline solution, directly to the nasal cavity via the nares, typically to clear and clean the mucous membrane and the nasal channels. Typically made of plastic or as a crockery vessel, the device may include a lid and separate base. It may be known as a nose horn because of its design or a Neti pot and is intended for home-use. This is a reusable device.	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: d499c9b0-c1c5-431f-8ae7-e731c67dd8d8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 05, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00744229100522	12	00744229440758		In Commercial Distribution	carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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