FDA.reportPublic FDA data

ETCO2 Sensor

Primary DI
06970706360668
Brand
ETCO2 Sensor
Company
Orantech Inc.
Model
CTM-RP01
Device description
ETCO2 SensorGeneral Meditech INC. Patient Monitor model G3C Compatible, Mainstream.
Published
2020-12-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K171828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171828000ETCO2 SensorOrantech, Inc.2018-05-31CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970706360668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970706360668069707063606686970706360668

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide monitorA mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream".

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544423370
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941691934233Orantech ET-3005R-PH-A2026-01-29
06941691934240Orantech ET-3005R-PH-I2026-01-29
06941691938279Orantech EL-PH3-90G-A2026-01-29
06941691948865Orantech EL-PH3-90G-I2026-01-29
06941691983132Orantech IBP-KR-MD0172026-01-29
06941691905431Orantech IBP-PH-2MIR402026-01-16
06941691982906Orantech IBP-GE-MD0172026-01-16
06941691982913Orantech IBP-SL-MD0172026-01-16
06941691982920Orantech IBP-NKB-MD0172026-01-16
06941691982937Orantech IBP-NKC-MD0172026-01-16
06941691982944Orantech IBP-DGB-MD0172026-01-16
06941691982951Orantech IBP-DGC-MD0172026-01-16
06941691982968Orantech IBP-DGD-MD0172026-01-16
06941691982975Orantech IBP-DGE-MD0172026-01-16
06941691982982Orantech IBP-MRB-MD0172026-01-16
06941691982999Orantech IBP-CR-MD0172026-01-16
06941691983002Orantech IBP-BLT-MD0172026-01-16
06941691983019Orantech IBP-KTN-MD0172026-01-16
06941691983026Orantech IBP-CL-MD0172026-01-16
06941691983033Orantech IBP-MEK-MD0172026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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
10612479282275McKessonMCKESSON 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