FDA.report

DRIVE

Primary DI
50822383132360
Brand
DRIVE
Company
Drive Devilbiss Healthcare
Model
MASK 003P
Device description
Respiratory Respiratory Disposables Product Description Pedi Ox Mask w/7'tub CS/50
Published
2020-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)

Product Code Classifications

CodeDeviceSpecialtyClass
KFZHumidifier, Non-Direct Patient Interface (Home-Use)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50822383132360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5082238313236050822383132360

GMDN Terms

TermDefinition
Aerosol face mask, non-rebreathingA flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.

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
true
Sterilization required before use
false

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