Clearflow, Inc.

Address:16 Technology Drive. Suite 150,Irvine,CA,92618,US

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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

Wound Drain Catheter System (OTK) (10) Catheter, Irrigation (GBX) (2)

Premarket Exempt

No Yes

Clear

PleuraFlow® System - 00856449006000 Catalog Number :

Device Description : PF-20 PleuraFlow® System

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System - 00856449006017 Catalog Number :

Device Description : PF-24 PleuraFlow® System

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System - 00856449006024 Catalog Number :

Device Description : PF-28 PleuraFlow® System

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System - 00856449006031 Catalog Number :

Device Description : PF-32 PleuraFlow® System

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006048 Catalog Number :

Device Description : PF-20 SEDL PleuraFlow® System with FlowGlide

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : GBX, OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006055 Catalog Number :

Device Description : PFFG-20 PleuraFlow® System with FlowGlide™

Device Class : 2

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006062 Catalog Number :

Device Description : PFFG-24 PleuraFlow® System with FlowGlide™

Device Class : 2

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006079 Catalog Number :

Device Description : PFFG-28 PleuraFlow® System with FlowGlide™

Device Class : 2

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006086 Catalog Number :

Device Description : PFFG-32 PleuraFlow® System with FlowGlide™

Device Class : 2

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006093 Catalog Number :

Device Description : PFFG-20 XDL PleuraFlow® System with FlowGlide

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK, GBX

Prescription Use : Yes

Device Count : 1

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