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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
Thoracic suction collection container FDA UDI
Device Name
PLEUR-EVAC SAHARA DRY SUCTION/DRY SEAL LATEX FREE FDA UDI
Model / Reference
IPN028484 FDA UDI
Description
PLEUR-EVAC SAHARA DRY SUCTION/DRY SEAL LATEX FREE FDA UDI

Identifiers

Catalog Number
S-1100-08LF FDA UDI
Primary DI / UDI-DI
34026704631668 FDA UDI
510(k) Number
K962856 FDA UDI
FDA Product Code
KDQ FDA UDI
GMDN Term
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
Total Volume — 2000 Milliliter FDA UDI
Length — 10.5 Inch FDA UDI
Width — 11.25 Inch FDA UDI
Depth — 3.5 Inch FDA UDI

Category: Thoracic suction collection container

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

Similar devices

Also classified as Thoracic suction collection container.

Cleared under the same submission

K962856 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 fd2e3d69-616d-4def-8d86-10e7e12bc0a9 37 fields · synced Jun 1, 2026