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Pleur Evac

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
PLEUR EVAC FDA UDI
PLEUR-EVAC FDA UDI
Generic Name
Pleural drainage system FDA UDI
Thoracic suction collection container FDA UDI
Device Name
PE INFANT WET LF FDA UDI
PLEUR-EVAC INFANT WET LATEX FREE FDA UDI
Model / Reference
IPN010610 FDA UDI
IPN928757 FDA UDI
IPN927566 FDA UDI
Description
PE INFANT WET LF FDA UDI
PLEUR-EVAC INFANT WET LATEX FREE FDA UDI

Identifiers

Catalog Number
A-8020-08LF FDA UDI
Primary DI / UDI-DI
34026704428862 FDA UDI
14026704921888 FDA UDI
14026704911940 FDA UDI
510(k) Number
K905768 FDA UDI
FDA Product Code
KDQ FDA UDI
GMDN Term
Pleural drainage system FDA UDI
Thoracic suction collection container FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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

Dimensions & Sizes

Size
Width — 6.5 Inch FDA UDI
Total Volume — 150 Milliliter FDA UDI
Length — 16.5 Inch FDA UDI
Depth — 2.5 Inch FDA UDI

Category: Pleural drainage system

Pleur Evac by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pleural drainage system.

Cleared under the same submission

K905768 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (3)

  • FDA UDI 189e1e2e-7576-4a17-b50e-7b9c5a02adaf 37 fields · synced Jun 8, 2026
  • FDA UDI a5762370-6edf-40f5-9711-fb5834ed6cea 37 fields · synced May 25, 2026
  • FDA UDI e5c63900-db3e-4c83-a0dc-36563374c352 37 fields · synced May 25, 2026