ORIDION MEDICAL 1987 LTD.

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

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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) (5)

Premarket Exempt

No Yes

Clear

Microstream Advance - 20884521771748 Catalog Number :

Device Description : Adult Nasal 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 - 20884521771755 Catalog Number :

Device Description : Pediatric Nasal 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 - 20884521777566 Catalog Number :

Device Description : Adult Oral-Nasal CO2 Filter 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 Advance - 20884521783987 Catalog Number :

Device Description : Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connector (MVA)

Device Class : 2

Duns Number: 600111512

Premarket Exempt : Yes

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 30884521520749 Catalog Number :

Device Description : Microstream Advance Hook and loop strap

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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