FDA.reportPublic FDA data

MicroStream

Primary DI
10884521209213
Brand
MicroStream
Company
ORIDION MEDICAL 1987 LTD.
Model
DSCS08657-01
Device description
Used CS20P (US) N W/PRINTER, DS
Published
2021-10-11
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
K123690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123690000CAPNOSTREAM20P WITH HIFI C02 MONITORINGOridion Medical 1987 , Ltd.2014-08-05CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521209213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452120921310884521209213

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521722927MicrostreamCS08651-032019-01-30
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

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