FDA.report

CSP Elongated Non-Rebreather Mask

Primary DI
10709078004589
Brand
CSP Elongated Non-Rebreather Mask
Company
WESTMED, INC.
Model
0368
Device description
Adult, CSP Elongated Non-rebreather mask w/o Safety Vent w/ 7' KROT, and threaded nut connector
Published
2017-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10709078004589PackageGS150In Commercial Distribution
00709078004582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800458910709078004589
00709078004582007090780045827090780045820709078004582

GMDN Terms

TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. 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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