EnviteC-Wismar GmbH

EnviteC-Wismar GmbH

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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, Oxygen, Gaseous-Phase (CCL) (8) Oximeter (DQA) (2)

Premarket Exempt

No Yes

Clear

OxiPen® - 04036616000178 Catalog Number : 1000155

Device Description : OxiPen® incl. F-3227

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

OxiPen® - 04036616000208 Catalog Number : 1000159

Device Description : OxiPen® incl. RM-3227

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000307 Catalog Number : 01-00-0114

Device Description : Oxygen Sensor OOM111

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000345 Catalog Number : 01-00-0013

Device Description : Oxygen Sensor OOM101

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000352 Catalog Number : 01-00-0019

Device Description : Oxygen Sensor OOM102

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000369 Catalog Number : E01-00-0020

Device Description : Oxygen Sensor OOM102-1

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : No

Device Count : 1

Oxygen Sensor - 04036616000376 Catalog Number : 01-00-0015

Device Description : Oxygen Sensor OOM103

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000383 Catalog Number : 01-00-0016

Device Description : Oxygen Sensor OOM103-1

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000390 Catalog Number : 01-00-0090

Device Description : Oxygen Sensor OOM103-1M

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Oxygen Sensor - 04036616000406 Catalog Number : 01-00-0049

Device Description : Oxygen Sensor OOM104

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

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