AccessGUDID - DEVICE: Protekt Nebulizer (05060488573620)

GUDID

Device Identifier (DI) Information

Brand Name: Protekt Nebulizer
Version or Model: PMNEBRDK-PP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMNEBRDK-PP
Company Name: PROACTIVE MEDICAL PRODUCTS, LLC

Primary DI Number: 05060488573620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078582655 *Terms of Use

Device Description: Protekt Pediatric Nebulizer w/ Disposable and Reusable Neb Kit, w/ Pediatric Mask - Pink Pig

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):	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?
12716	Benchtop nebulizer, heated	An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (direct patient interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123030	000

Device Exempt from Premarket Submission: No 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
Length: 6 Inch
Height: 8 Inch
Width: 9 Inch

Device Record Status

Public Device Record Key: b8c2ba20-02cd-45fd-a476-1b50a1fd13a0
Public Version Date: November 28, 2022
Public Version Number: 1
DI Record Publish Date: November 18, 2022