AccessGUDID - DEVICE: MABIS (00767056403659)

GUDID

Device Identifier (DI) Information

Brand Name: MABIS
Version or Model: 40-365-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 40-365-000
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 00767056403659
Issuing Agency: GS1
Commercial Distribution End Date: May 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: NEBPAK BOY ULTRASONIC NEBUILIZER

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):	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?
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 [?]
K002831	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
No Device Sizes

Device Record Status

Public Device Record Key: ccad74ec-d16d-4d08-a795-626372b3c7b4
Public Version Date: May 17, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 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
10767056403656	2	30767056403650	2023-05-16	Not in Commercial Distribution	Master Carton
30767056403650	3	00767056403659	2023-05-16	Not in Commercial Distribution	Inner Carton