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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
Whole-blood-recovery autotransfusion system, powered FDA UDI
Device Name
PE SAHARA ATS BAG LF FDA UDI
Model / Reference
IPN025420 FDA UDI
Description
PE SAHARA ATS BAG LF FDA UDI

Identifiers

Catalog Number
S-100-08LF FDA UDI
Primary DI / UDI-DI
04026704410842 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Whole-blood-recovery autotransfusion system, powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5830 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 11 Inch FDA UDI
Width — 5.5 Inch FDA UDI
Depth — 2.5 Inch FDA UDI

Category: Whole-blood-recovery autotransfusion system, powered

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

Similar devices

Also classified as Whole-blood-recovery autotransfusion system, powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 4dd4620d-fbd5-45cc-9cee-27ebcf5f1a73 36 fields · synced May 30, 2026