FDA.report

Pediatric Elongated Venturi Mask Kit

Primary DI
10709078004633
Brand
Pediatric Elongated Venturi Mask Kit
Company
WESTMED, INC.
Model
3227-E
Device description
Pediatric Venturi Mask w/ Diluters, Aerosol Tubing/Hood, 8' oxygen tubing and TN
Published
2017-08-31
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
BYFMask, Oxygen, Low Concentration, Venturi

Product Code Classifications

CodeDeviceSpecialtyClass
BYFMask, Oxygen, Low Concentration, VenturiAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078004633PackageGS150In Commercial Distribution
00709078004636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800463310709078004633
00709078004636007090780046367090780046360709078004636

GMDN Terms

TermDefinition
Venturi oxygen face maskA flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. 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
true
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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