FDA.report

POCKET AIR

Primary DI
14719874690042
Brand
POCKET AIR
Company
MICROBASE TECHNOLOGY CORP.
Model
MBPN00200
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14719874690042PackageGS1150In Commercial Distribution
04719874690045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1471987469004214719874690042
04719874690045047198746900454719874690045

GMDN Terms

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

Regulatory Flags

DUNS number
658434951
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04719874690076POCKET AIRMBPN002032020-06-03
14719874690080POCKET AIRMBPN002042020-06-03
14719874690097POCKET AIRMBPN002072020-06-03
14719874690059POCKET AIRMBPN002012020-05-31
14719874690066POCKET AIRMBPN0022020-05-31
04719874690014Mini NebNB502020-03-27
04719874690021Mini NebNB50-MC2020-03-27
14719874690035Mini NebNB502020-03-27

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