FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
00872237001088
Brand
GLOBAL HEALTHCARE
Company
GHC HEALTHCARE, INC.
Model
63-4530
Device description
ADULT NASAL CANNULA O2/CO2, 7' LENGHT, MALE LUER, STANDARD O2 CONNECTOR
Published
2017-02-10
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
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
40872237001086PackageGS125In Commercial Distribution
00872237001088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700108640872237001086
00872237001088008722370010888722370010880872237001088

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
884718776
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
00872237001804GLOBAL HEALTHCARE60-T022023-03-16
40872237001802GLOBAL HEALTHCARE60-T022023-03-16
00872237008568GLOBAL HEALTHCARE60-TN14012017-02-10
00872237001095GLOBAL HEALTHCARE63-45312017-02-10
00872237001101GLOBAL HEALTHCARE63-45322017-02-10
00872237004256GLOBAL HEALTHCAREUB-LE6002016-09-12
00872237005192GLOBAL HEALTHCARE81-0012016-09-12
00872237005208GLOBAL HEALTHCARE81-0022016-09-12
00872237008674GLOBAL HEALTHCARE81-003A2016-09-12
00872237008681GLOBAL HEALTHCARE81-004A2016-09-12
00872237008698GLOBAL HEALTHCARE81-005A2016-09-12
00872237008711GLOBAL HEALTHCARE81-007A2016-09-12
00872237009114GLOBAL HEALTHCARE07-21M 2020-08-04
00872237009121GLOBAL HEALTHCARE07-21L2020-08-04
00872237009138GLOBAL HEALTHCARE07-21XL2020-08-04
00872237009145GLOBAL HEALTHCARE07-21XXL2020-08-04
00872237004263GLOBAL HEALTHCAREUB-PC2016-09-12
00872237004270GLOBAL HEALTHCAREUB-RC2016-09-12
00872237004751GLOBAL HEALTHCAREUB-P2016-09-12
00872237005109GLOBAL HEALTHCARE60-T1652017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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