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Pleur Evac

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
PLEUR EVAC FDA UDI
Generic Name
Pleural drainage system FDA UDI
Device Name
PE ADULT-PED WET LF INTL ENG FDA UDI
Model / Reference
IPN010605 FDA UDI
Description
PE ADULT-PED WET LF INTL ENG FDA UDI

Identifiers

Catalog Number
A-8000I FDA UDI
Primary DI / UDI-DI
34026704410089 FDA UDI
510(k) Number
K905768 FDA UDI
FDA Product Code
KDQ FDA UDI
GMDN Term
Pleural drainage system 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
Depth — 2.5 Inch FDA UDI
Width — 11 Inch FDA UDI
Total Volume — 2500 Milliliter FDA UDI
Length — 16.5 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 (1)

  • FDA UDI ac1d706a-0484-4005-a6ee-f3eb629a86e7 37 fields · synced Jun 7, 2026