FDA.report

MADA Non-Rebreather Masks

Primary DI
10709078002523
Brand
MADA Non-Rebreather Masks
Company
WESTMED, INC.
Model
53226
Device description
Mask, Pediatric Non-Rebreather W/Safety Vent,7' KROT, and TN
Published
2017-04-14
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
10709078002523PackageGS150In Commercial Distribution
00709078002526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800252310709078002523
00709078002526007090780025267090780025260709078002526

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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20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
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07045432119312Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
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00840117345256Resp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant Dynarex CorporationKGB2025-05-30
00840117345263Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30