FDA.reportPublic FDA data

Comfort Soft Plus CO2/O2 Mask

Primary DI
00709078001697
Brand
Comfort Soft Plus CO2/O2 Mask
Company
WESTMED, INC.
Model
0562
Device description
"adult CO2/O2 Mask, 10' x 0.050 GSL w swivel elbow, 2"" Pigtail w/ female luer connectors, 7' oxygen supply tubing"
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078001694PackageGS150In Commercial Distribution
00709078001697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800169410709078001694
00709078001697007090780016977090780016970709078001697

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Lot or batch
true
No natural rubber latex
true

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00709078014284Bubble Humidifier10022482022-03-31
00709078003011Composite Kit07922017-04-26
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00709078003974A-Line3100-302021-01-31
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00709078009082Pulset3173-142020-08-31

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