Vacumed

Vacumed

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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

COMPUTER, OXYGEN-UPTAKE (BZL) (8) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (1) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (1)

Premarket Exempt

No Yes

Clear

Gold Edition Carbon Dioxide Analyzer - 00850644007008 Catalog Number : 17515

Device Description : CO2 Analyzer

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

Gold Edition O2 Analyzer - 00850644007015 Catalog Number : 17518

Device Description : O2 Analyzer

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : CCL

Prescription Use : No

Device Count : 1

Cardiopulmonary stress exercise monitoring system - 00850644007022 Catalog Number : YD17590

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista-MX Metabolic Measurement System - 00850644007039 Catalog Number : 17590

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista-MX (Gold Edition) - 00850644007046 Catalog Number : 17593

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista-MX2 - 00850644007053 Catalog Number : 17594

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista MX2 (Gold Edition) - 00850644007060 Catalog Number : 17594G

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista Mini-CPX Silver Edition - 00850644007077 Catalog Number : 17670

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista Interface - 00850644007084 Catalog Number : 17001

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

Vista Interface w/turbine flow sensor - 00850644007091 Catalog Number : 17003

Device Description : Vista Interface System

Device Class : 2

Duns Number: 077967081

Premarket Exempt : No

Product Code : BZL

Prescription Use : No

Device Count : 1

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