FDA.reportPublic FDA data

McKesson

Primary DI
10612479282275
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-0539-B
Device description
CANNULA, NASAL GAS SAMP 02 CO2FML ADLT 10'
Published
2026-04-14
Public version status
New
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
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143150000CO2 monitoring line with and without in-line filterBesmed Health Business Corp2015-02-05CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479282283PackageGS125In Commercial Distribution
10612479282275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247928228340612479282283
1061247928227510612479282275

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA 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.

Regulatory Flags#

DUNS number
023904428
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282299McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282312McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
09555866301385DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2026-04-02
10197344162550MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
10197344162567MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
09555866300869DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
10884389815311MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
10884389815069MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
10197344111107MEDLINEMEDLINE INDUSTRIES, INC.CCK2024-09-09
10841522126413TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCCK2024-07-16
10843997017685NomolineMASIMO CORPORATIONCCK2024-03-19
10620974003684Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2024-01-26
10620974003097Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003103Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003127Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003134Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003158Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003165Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003172Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003189Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003202Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003219Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003226Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003608Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003615Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003622Oxy2ProSouthmedic IncorporatedCCK2023-12-01