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) (9) Bottle, Collection, Vacuum (KDQ) (1)

Premarket Exempt

No Yes

Clear

PleuraFlow® System with FlowGlide - 00856449006109 Catalog Number :

Device Description : PFFG-24 XDL 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 - 00856449006116 Catalog Number :

Device Description : PFFG-24 RA 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 - 00856449006123 Catalog Number :

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

Device Class : 2

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® POD - 00856449006130 Catalog Number :

Device Description : High Capacity Dry Thoracic Drainage Pod-2400 mL Dual Chamber

Device Class : 2

Duns Number: 827428223

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

PleuraFlow® System with FlowGlide - 00856449006147 Catalog Number :

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

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

PleuraFlow® ZIP - 00856449006161 Catalog Number :

Device Description : The ZIP, Accessory Shuttle for PleuraFlow® System

Device Class : 2

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

Pleuraflow® System with FlowGlide - 00856449006178 Catalog Number :

Device Description : PFFG3-20 Pleuraflow® System with FlowGlide

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

Pleuraflow® System with FlowGlide - 00856449006185 Catalog Number :

Device Description : PFFG3-24 Pleuraflow® System with FlowGlide

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

Pleuraflow® System with FlowGlide - 00856449006192 Catalog Number :

Device Description : PFFG3-28 Pleuraflow® System with FlowGlide

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

Pleuraflow® System with FlowGlide - 00856449006208 Catalog Number :

Device Description : PFFG3-32 Pleuraflow® System with FlowGlide

Device Class :

Duns Number: 827428223

Premarket Exempt : No

Product Code : OTK

Prescription Use : Yes

Device Count : 1

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