FDA.reportPublic FDA data

CO2 Sampling Nasal Cannula

Primary DI
10709078001656
Brand
CO2 Sampling Nasal Cannula
Company
WESTMED, INC.
Model
0874
Device description
CO2 Sampling Nasal Cannula 15" w/female luer
Published
2017-01-06
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

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078001656PackageGS150In Commercial Distribution
00709078001659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800165610709078001656
00709078001659007090780016597090780016590709078001659

GMDN Terms#

Term, Definition table
TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078000515Nebulizer02232016-11-24
00709078000560Nebulizer03252016-11-24
00709078000614Nebulizer02052016-11-24
00709078006197VixOne Nebulizer02332018-11-30
20889483528614AMBU Hyperinflation System900 000 6142026-03-05
20889483528737AMBU Hyperinflation System900 000 6172026-03-05
20889483528751AMBU Hyperinflation System900 000 6182026-03-05
20889483528867AMBU Hyperinflation System900 000 6242026-03-05
20889483528942AMBU Hyperinflation System900 000 6282026-03-05
20889483568795AMBU Hyperinflation System900 000 6012026-03-05
20889483542801AMBU Hyperinflation System900 000 6022026-03-05
20889483542849AMBU Hyperinflation System900 000 6042026-03-05
20889483542863AMBU Hyperinflation System900 000 6052026-03-05
20889483542887AMBU Hyperinflation System900 000 6062026-03-05
20889483542924AMBU Hyperinflation System900 000 6092026-03-05
20889483542962AMBU Hyperinflation System900 000 6112026-03-05
10709078000574VixOneVOID 02482025-11-24
00709078049996FilterVoid OU812b2025-09-23
00709078050008FilterVoid OU812a2025-09-23
10709078008402Flex Extenders7-51322024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
44710810083325N/AGALEMED CORPORATIONCAI2026-03-05
44710810085558N/AGALEMED CORPORATIONCAI2026-03-05
44710810087682N/AGALEMED CORPORATIONCAI2026-03-05
44710810088559N/AGALEMED CORPORATIONCAI2026-03-05
44710810101319N/AGALEMED CORPORATIONCAI2026-03-05
44710810103504N/AGALEMED CORPORATIONCAI2026-03-05
44710810105720N/AGALEMED CORPORATIONCAI2026-03-05
44710810105737N/AGALEMED CORPORATIONCAI2026-03-05
44710810110915N/AGALEMED CORPORATIONCAI2026-03-05
44710810116108N/AGALEMED CORPORATIONCAI2026-03-05
44710810080867N/AGALEMED CORPORATIONCAI2026-03-04
44710810087859N/AGALEMED CORPORATIONCAI2026-03-04
44710810088474N/AGALEMED CORPORATIONCAI2026-03-04
44710810089808N/AGALEMED CORPORATIONCAI2026-03-04
44710810103146N/AGALEMED CORPORATIONCAI2026-03-04
44710810114098N/AGALEMED CORPORATIONCAI2026-03-04
44710810116092N/AGALEMED CORPORATIONCAI2026-03-04
44710810116924N/AGALEMED CORPORATIONCAI2026-03-04
20889483300135Respan®SUNMED, LLCCAI2026-02-11
46923980110359N/AGaleMed Xiamen Co., Ltd.CAI2026-02-05
M368H0678972HAUSTEDGF HEALTH PRODUCTS, INC.CAI2025-10-31
00612649214559UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649130972JACKSON REESKing Systems CorporationCAI2023-01-18
00612649214047UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214030UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214078UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214092UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214115UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214139UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214153UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18