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 - 20884521761848 Catalog Number :

Device Description : Adult Nasal CO2 Filter 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 Advance - 20884521761855 Catalog Number :

Device Description : Adult Nasal CO2 Filter 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 Advance - 20884521761862 Catalog Number :

Device Description : Adult Nasal CO2 Filter 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 Advance - 20884521761879 Catalog Number :

Device Description : Pediatric Nasal CO2 Filter 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 Advance - 20884521761886 Catalog Number :

Device Description : Adult-Pediatric Intubated CO2 Filter Line; Short-term: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521761893 Catalog Number :

Device Description : Adult-Pediatric Intubated 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 - 20884521761909 Catalog Number :

Device Description : Adult-Pediatric Intubated 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 - 20884521761916 Catalog Number :

Device Description : Adult-Pediatric 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 - 20884521761923 Catalog Number :

Device Description : Microstream Advance Adult-Pediatric Intubated Filter Line

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521761930 Catalog Number :

Device Description : Adult-Pediatric Intubated CO2 Filter Line; Extended Duration

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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