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 small - 04036616002295 Catalog Number : 06-00-0729

Device Description : SoftTip small RS-3512-40 Datex

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip small - 04036616002301 Catalog Number : 06-00-0815

Device Description : SoftTip small RS-3512-9 Datex

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002349 Catalog Number : 06-00-1361

Device Description : SoftTip® medium RM-2182-3 Minolta

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002370 Catalog Number : 06-00-1364

Device Description : SoftTip® medium RM-2412 HP/Phillips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002387 Catalog Number : 06-00-1365

Device Description : SoftTip® medium RM-2414-15 HP/Philips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002394 Catalog Number : 06-00-1366

Device Description : SoftTip® medium RM-2414-30 HP/Philips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002400 Catalog Number : 06-00-1369

Device Description : SoftTip® medium RM-3212-9 Nellcor

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002424 Catalog Number : 06-00-1370

Device Description : SoftTip® medium RM-3222-12 BCI

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002448 Catalog Number : 06-00-1371

Device Description : SoftTip® medium RM-3227 EnviteC

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616002486 Catalog Number : 06-00-1377

Device Description : SoftTip® medium RM-3412 Ohmeda

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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