MADA MEDICAL PRODUCTS,INC. 277

GUDID 00815160020573

An assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

MADA MEDICAL PRODUCTS, INC

Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated
Primary Device ID00815160020573
NIH Device Record Key4a03e6e8-895e-483d-a1b0-e68d83729f17
Commercial Distribution StatusIn Commercial Distribution
Brand NameMADA MEDICAL PRODUCTS,INC.
Version Model Number277
Catalog Number277
Company DUNS048411862
Company NameMADA MEDICAL PRODUCTS, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com
Phone201-460-0454
Emailjeffadam@madamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815160020573 [Primary]

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-20
Device Publish Date2018-08-20

On-Brand Devices [MADA MEDICAL PRODUCTS,INC.]

00815160020597An assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dis
00815160020573An assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dis
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