FDA.reportPublic FDA data

Microstream Luer

Primary DI
20884521762142
Brand
Microstream Luer
Company
ORIDION MEDICAL 1987 LTD.
Model
MLAI
Device description
Adult-Pediatric Intubated Sampling Line, Short-term use: Procedural/Emergency
Published
2020-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
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
K181467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181467000Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineOridion Medical 1987 , Ltd.2019-02-08CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521762145PackageGS125In Commercial Distribution
20884521762142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452176214510884521762145
2088452176214220884521762142

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
600111512
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
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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