MADA MEDICAL PRODUCTS,INC. 277-220V

GUDID 00815160020597

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.220 VOLT

MADA MEDICAL PRODUCTS, INC

Nebulizing system, non-heated

• Primary Device ID: 00815160020597
• NIH Device Record Key: b43d08e1-fb99-4123-97de-19b645dcb046
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MADA MEDICAL PRODUCTS,INC.
• Version Model Number: 277-220V
• Catalog Number: 277-220V
• Company DUNS: 048411862
• Company Name: MADA MEDICAL PRODUCTS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com
• Phone: 201-460-0454
• Email: dianelind@madamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815160020597 [Primary]

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-20
• Device Publish Date: 2018-08-20

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

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