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

Oximeter (DQA) (10)

Premarket Exempt

No Yes

Clear

SoftTip large - 04036616002035 Catalog Number : 06-00-0771

Device Description : SoftTip large R-3412-10 Ohmeda

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616002066 Catalog Number : 06-00-0727

Device Description : SoftTip large R-3512-40 Datex

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616002073 Catalog Number : 06-00-0766

Device Description : SoftTip large R-3512-9 Datex

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002127 Catalog Number : 06-00-0591

Device Description : SoftTip small RS-2182-3 Minolta

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002158 Catalog Number : 06-00-0726

Device Description : SoftTip small RS-2412 HP/Philips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002172 Catalog Number : 06-00-0724

Device Description : SoftTip small RS-2414-15 HP/Philips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002196 Catalog Number : 06-00-0712

Device Description : SoftTip small RS-3212-9 Nellcor

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002202 Catalog Number : 06-00-0583

Device Description : SoftTip small RS-3222-12 BCI

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002257 Catalog Number : 06-00-0716

Device Description : SoftTip small RS-3412 Ohmeda

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002264 Catalog Number : 06-00-0822

Device Description : SoftTip small RS-3412-10 Ohmeda

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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