ORIDION MEDICAL 1987 LTD.

Address:7 HAMARPE ST. P.O. BOX 45025,JERUSALEM,IL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (10)

Premarket Exempt

No Yes

Clear

Microstream Advance - 20884521761947 Catalog Number :

Device Description : Filter Line, MRI XL, Short-term use: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521761954 Catalog Number :

Device Description : CO2 Filter Line; Short-term use: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521761985 Catalog Number :

Device Description : Neonatal-Infant Intubated CO2 Filter Line; Extended Duration

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521761992 Catalog Number :

Device Description : Neonatal-Infant Intubated CO2 Filter Line; Extended Duration

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521762005 Catalog Number :

Device Description : Adult-Pediatric Intubated CO2 Filter Line; High Humidity

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521762012 Catalog Number :

Device Description : Neonatal-Infant Intubated CO2 Filter Line; High Humidity

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Luer - 20884521762043 Catalog Number :

Device Description : Microstream Luer Adult Oral-Nasal Sampling Line with O2 connector

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Luer - 20884521762050 Catalog Number :

Device Description : Adult Oral-Nasal CO2 Sampling Line with O2 Tubing; Short-term use: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Luer - 20884521762067 Catalog Number :

Device Description : Adult Oral-Nasal CO2 Sampling Line with O2 Connector; Short-term use: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Luer - 20884521762074 Catalog Number :

Device Description : Adult Oral-Nasal CO2 Sampling Line with O2 Tubing; Short-term use: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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