Oxygen
Oxygen
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2225311 | 2225311 | MADA MEDICAL PRODUCTS, INC. | 1 | Y | 2026-01-01 | 625 WASHINGTON AVE. CARLSTADT NJ US 07072 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00815160020573 | MADA MEDICAL PRODUCTS,INC. - 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. | 201-460-0454 | jeffadam@madamedical.com |
| 00815160020573 | MADA MEDICAL PRODUCTS,INC. - 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. | 201-460-0454 | dianelind@madamedical.com |
| 00815160020597 | MADA MEDICAL PRODUCTS,INC. - 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 | 201-460-0454 | dianelind@madamedical.com |
| 00815160020597 | MADA MEDICAL PRODUCTS,INC. - 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 | 201-460-0454 | jeffadam@madamedical.com |
| 00815160021129 | MADA MEDICAL PRODUCTS, INC. - A portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use. | (201)460-0454 | dianelind@madamedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36151 | 1784138810 | K850754 | MEDAJET XL - JET INJECTOR | KZE | 1985-12-10 |
| 36151 | 1833423747 | K042349 | EMG MODEL SUA01 SUCTION UNIT | JCX | 2004-12-16 |
| 36151 | 1725602600 | ||||
| 36151 | 1761159241 | ||||
| 36151 | 1133330358 | ||||
| 36151 | 1144415845 | ||||
| 36151 | 1469588215 | ||||
| 36151 | 1474440795 | ||||
| 36151 | 1654886725 | ||||
| 36151 | 1657622465 | ||||
| 36151 | 1743321965 | ||||
| 36151 | 1886894797 | ||||
| 36151 | 1943361481 |
MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC.
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