FDA.report

Adult Venturi Fixed Concentration Mask with 60% Barrel + 2.1m O2 Tube

Primary DI
05055788757665
Brand
Adult Venturi Fixed Concentration Mask with 60% Barrel + 2.1m O2 Tube
Company
FLEXICARE MEDICAL LIMITED
Model
032-10-044TU
Published
2020-01-28
Public version status
New
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
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788757665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788757665050557887576655055788757665

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
504406273
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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