DEVICE: PLEUR-EVAC (34026704631668)

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Device Record History
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Device Identifier (DI) Information
PLEUR-EVAC
IPN028484
In Commercial Distribution
S-1100-08LF
TELEFLEX INCORPORATED
34026704631668
GS1

1
002348191 *Terms of Use
34026704428909
PLEUR-EVAC SAHARA DRY SUCTION/DRY SEAL LATEX FREE
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Device Characteristics
Labeling does not contain MRI Safety Information
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?
63652 Thoracic suction collection container
A device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KDQ BOTTLE, COLLECTION, VACUUM
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K962856 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 2000 Milliliter
Length: 10.5 Inch
Width: 11.25 Inch
Depth: 3.5 Inch
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Device Record Status
fd2e3d69-616d-4def-8d86-10e7e12bc0a9
September 08, 2025
4
July 09, 2019
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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
44026704631665 6 34026704631668 In Commercial Distribution Case
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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
Yes
14026704631664
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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