FDA.reportPublic FDA data

Microstream

Primary DI
10884521799615
Brand
Microstream
Company
ORIDION MEDICAL 1987 LTD.
Model
PMC40M-GE
Device description
CARESCAPE (TM) CO2-Microstream (TM) Parameter;For use with GE Patient Monitors
Published
2022-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K213518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213518000CARESCAPE CO2 Microstream parameterCovidien, LLC2022-04-12CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521799615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452179961510884521799615

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".

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure100 Millimeter of Mercury150 Millimeter of Mercury
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Special Storage Condition, Specify00Fragile, Keep dry, This side up (refer to IFU)
Storage Environment Atmospheric Pressure11 KiloPascal108 KiloPascal
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
600111512
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521551906Microstream015179_RMS12016-09-30
20884521551999Microstream0111082016-09-30
20884521761787Microstream AdvanceMVINH2020-07-04
20884521761794Microstream AdvanceMVINHL2020-07-04
20884521761800Microstream AdvanceMVINOH2020-07-23
20884521761824Microstream AdvanceMVANOH2020-07-23
20884521771731Microstream AdvanceMVIN2020-08-05
10884521552104Microstream012521_RMS12018-01-11
10884521551954Microstream015776_RMS12018-01-11
20884521761565Microstream AdvanceMVA2020-01-09
20884521761572Microstream AdvanceMVAL2020-01-09
20884521761589Microstream AdvanceMVAL100U2020-01-30
20884521761596Microstream AdvanceMVAO2020-02-28
20884521761602Microstream AdvanceMVAO100U2020-02-28
20884521761619Microstream AdvanceMVAOL2020-01-09
20884521761626Microstream AdvanceMVAOL100U2020-01-30
20884521761640Microstream AdvanceMVPO2020-01-09
20884521761657Microstream AdvanceMVPOL2020-01-09
20884521761664Microstream AdvanceMVAOH2020-07-04
20884521761671Microstream AdvanceMVAOH100U2020-07-04

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Primary DI, Brand, Company table
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10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14