Pall Posidyne® ELD Filter

FDA UDI

Class II (US FDA UDI)

by Global Life Sciences Solutions USA LLC

Identity

Trade Name: Pall Posidyne® ELD Filter FDA UDI
Generic Name: Intravenous line filter FDA UDI
Device Name: 0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing, Y injection site and luer lock adapter FDA UDI
Model / Reference: ELD96LYLS FDA UDI
Description: 0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing, Y injection site and luer lock adapter FDA UDI

Identifiers

Catalog Number: ELD96LYLS FDA UDI
Primary DI / UDI-DI: 00636207000347 FDA UDI
510(k) Number: K850825 FDA UDI
FDA Product Code: FPB FDA UDI
GMDN Term: Intravenous line filter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Pore Size — 0.2 Micrometer FDA UDI

Category: Intravenous line filter

Pall Posidyne® ELD Filter by Global Life Sciences Solutions USA LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K850825 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Global Life Sciences Solutions USA LLC

Sources (1)

FDA UDI ece7d404-a1de-4da5-8ed2-80cadb6575bf 37 fields · synced May 29, 2026