Avante

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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) (4) Analyzer, Gas, Oxygen, Gaseous-Phase (CCL) (3) System, Monitoring, Perinatal (HGM) (3)

Premarket Exempt

No Yes

Clear

Nasal CO2 Sampling Cannula With O2 Delivery - 00815871020107 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

Nasal CO2 Sampling Cannula With O2 Delivery - 00815871020114 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

Nasal CO2 Sampling Cannula With O2 Delivery - 00815871020121 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

Nasal CO2 Sampling Cannula With O2 Delivery - 00815871020138 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

1000 Anesthesia Replacement Oxygen Cell - 00815871020169 Catalog Number :

Device Description : DRE 1000 Labeled (MAX-1)

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCL

Prescription Use : No

Device Count : 1

2000 Anesthesia Replacement Oxygen Cell - 00815871020176 Catalog Number :

Device Description : DRE 2000 Labeled (MAX-11)

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCL

Prescription Use : No

Device Count : 1

6000 Anesthesia Replacement Oxygen Cell - 00815871020183 Catalog Number :

Device Description : DRE 6000 Labeled (MAX-12)

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : CCL

Prescription Use : No

Device Count : 1

Compact FM - 00815871020190 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact FM - 00815871020206 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Compact FM - 00815871020213 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

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