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PleuraFlow® System with FlowGlide

FDA UDI

Class I (US FDA UDI)

by Clearflow, Inc

Identity

Trade Name
PleuraFlow® System with FlowGlide FDA UDI
Generic Name
Closed-wound drain, non-bioabsorbable FDA UDI
Device Name
PF-20 SEDL PleuraFlow® System with FlowGlide FDA UDI
Model / Reference
PF-20 SEDL FDA UDI
Description
PF-20 SEDL PleuraFlow® System with FlowGlide FDA UDI

Identifiers

Primary DI / UDI-DI
00856449006048 FDA UDI
510(k) Number
K153681 FDA UDI
FDA Product Code
GBX FDA UDI
OTK FDA UDI
GMDN Term
Closed-wound drain, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 20 French FDA UDI

Category: Closed-wound drain, non-bioabsorbablePleural catheterMediastinal drainage catheter, non-antimicrobial

PleuraFlow® System with FlowGlide by Clearflow, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mediastinal drainage catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clearflow, Inc

Sources (1)

  • FDA UDI ad91ffa3-c625-4e0c-844f-f3523f4c8697 37 fields · synced May 30, 2026