FDA.report

DRIVEMEDICAL

Primary DI
00822383274492
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
O-224
Device description
RespiratoryConservers Product Description: Oxymizer Mustach- 24/Case
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NFBConserver, oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50822383274497PackageGS124In Commercial Distribution
00822383274492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238327449750822383274497
00822383274492008223832744928223832744920822383274492

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
867673159
Device count
1
DM exempt
false
Premarket exempt
true
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

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