FDA.report

Mask, Adult, Non-Rebreather, W/Safety Vent, 7' KROT

Primary DI
10709078003582
Brand
Mask, Adult, Non-Rebreather, W/Safety Vent, 7' KROT
Company
WESTMED, INC.
Model
1326
Device description
Mask, Adult, Non-Rebreather, W/Safety Vent, 7' KROT, And TN
Published
2017-04-18
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
true

Related Records

Product Codes

CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078003582PackageGS150In Commercial Distribution
00709078003585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800358210709078003582
00709078003585007090780035857090780035850709078003585

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
092673953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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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