FDA.reportPublic FDA data

MADA MEDICAL PRODUCTS,INC.

Primary DI
00815160020573
Brand
MADA MEDICAL PRODUCTS,INC.
Company
MADA MEDICAL PRODUCTS, INC
Model
277
Catalog number
277
Device description
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.
Published
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815160020573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815160020573008151600205738151600205730815160020573

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-460-0454jeffadam@madamedical.com
201-460-0454dianelind@madamedical.com

Regulatory Flags#

DUNS number
048411862
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815160020597MADA MEDICAL PRODUCTS,INC.277-220V277-220V2018-08-20
00815160021310MADA MEDICAL PRODUCTS, INC.R1836GBHF-25GPR1836GBHF-25GP2024-04-22
00815160021129MADA MEDICAL PRODUCTS, INC.7000-MVP7000-MVP2023-06-27
00815160020498MADA MEDICAL PRODUCTS, INC.1301M1301M2023-09-02
00815160020504MADA MEDICAL PRODUCTS, INC.1301ME1301ME2023-09-02
00815160021280MADA MEDICAL PRODUCTS, INC.R1835-25GBHF-25R1835-25GBHF-252023-09-02
00815160021297MADA MEDICAL PRODUCTS, INC.1415MS1415MS2023-09-02
00815160021303MADA MEDICAL PRODUCTS, INC.1529E1529E2023-09-02
00815160021327MADA MEDICAL PRODUCTS, INC.1515A-151515A-152023-09-02
00815160021334MADA MEDICAL PRODUCTS, INC.1630-151630-152023-09-02
00815160021341MADA MEDICAL PRODUCTS, INC.1630-A151630-A152023-09-02
00815160021358MADA MEDICAL PRODUCTS, INC.1630A-15E1630A-15E2023-09-02
00815160021365MADA MEDICAL PRODUCTS, INC.163016302023-09-02
00815160021372MADA MEDICAL PRODUCTS, INC.1616-15E1616-15E2023-09-02
00815160021389MADA MEDICAL PRODUCTS, INC.1630M-15E1630M=15E2023-09-02
00815160021396MADA MEDICAL PRODUCTS, INC.1616-AE1616-AE2023-09-02
00815160021235MADA MEDICAL PRODUCTS, INC.1701-A1701-A2023-08-05
00815160021242MADA MEDICAL PRODUCTS, INC.1701-81701-82023-08-05
00815160021259MADA MEDICAL PRODUCTS, INC.135913592023-08-05
00815160021266MADA MEDICAL PRODUCTS, INC.1359-11359-12023-08-05

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