FDA.reportPublic FDA data

Microstream

Primary DI
10884521591745
Brand
Microstream
Company
ORIDION MEDICAL 1987 LTD.
Model
PM35MN05
Device description
CAPNOSTREAM 35 PORTABLE RESPIRATORY MONITOR-BRAZIL
Published
2021-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K150272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150272000Capnostream 35 Portable Respiratory MonitorOridion Medical 1987 , Ltd.2015-07-17CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521591745Direct MarkingGS10
10884521741997PrimaryGS10
10884521786936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452159174510884521591745
1088452174199710884521741997
1088452178693610884521786936

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
Special Storage Condition, Specify00No

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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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