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 Luer - 20884521762098 Catalog Number :

Device Description : Pediatric Oral-Nasal CO2 Sampling Line with O2 Tubing; Short-term use: Procedura Pediatric 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 - 20884521762104 Catalog Number :

Device Description : Adult 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 - 20884521762111 Catalog Number :

Device Description : Pediatric 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 - 20884521762128 Catalog Number :

Device Description : Adult-Intermediate Bite Block CO2 Sampling Line with O2 tubing; Short-term use: Adult-Intermediate Bite Block 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 - 20884521762135 Catalog Number :

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Luer - 20884521762142 Catalog Number :

Device Description : Adult-Pediatric Intubated Sampling 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 Luer - 20884521762159 Catalog Number : 010989

Device Description : Airway Adapter

Device Class : 2

Duns Number: 600111512

Premarket Exempt : Yes

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Luer - 20884521762166 Catalog Number :

Device Description : CO2 Sampling 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 Luer - 20884521762388 Catalog Number :

Device Description : Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing; Short-term use: Pr Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency

Device Class : 2

Duns Number: 600111512

Premarket Exempt : Yes

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Microstream Advance - 20884521771731 Catalog Number :

Device Description : Neonatal-Infant Nasal CO2 Filter Line

Device Class : 2

Duns Number: 600111512

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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