DEVICE: PleuraFlow® System with FlowGlide (00856449006062)

Device Identifier (DI) Information

PleuraFlow® System with FlowGlide
PFFG-24
In Commercial Distribution

Clearflow, Inc.
00856449006062
GS1

1
827428223 *Terms of Use
PFFG-24 PleuraFlow® System with FlowGlide™
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
11305 Closed-wound drain, non-bioabsorbable
A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
Active false
37482 Pleural catheter
A tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.
Active false
32544 Mediastinal drainage catheter, non-antimicrobial
A tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
OTK Wound Drain Catheter System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163139 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature, humidity and ultraviolet light
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 24 French
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Device Record Status

7e39d4ce-38a7-4b81-84af-db95bf650508
January 03, 2024
9
April 17, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20856449006066 1 10856449006069 In Commercial Distribution Case
10856449006069 10 00856449006062 In Commercial Distribution Inner Pack
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
844-257-3569
customerservice@clearflow.com
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