PALL CORPORATION

Address:25 HARBOR PARK DR,Port Washington,NY,11050,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Filter, bacterial, breathing-circuit (CAH) (5) Filter, infusion line (FPB) (5)

Premarket Exempt

No Yes

Clear

Pall Posidyne® ELD Filter - 00636207000125 Catalog Number : ELD96NT

Device Description : 0.2 micron Intravenous Filter for 96 Hour Use with Luer-Lock Outlet Port

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall Conserve™ Small Volume HME - 00636207000231 Catalog Number : BB25A

Device Description : Conserve Small Volume HME with Monitoring Port. For use with mechanically ventil Conserve Small Volume HME with Monitoring Port. For use with mechanically ventilated patientsto retain heat and humidity while removing bacterial/viral contaminants with an efficiency of99.999%.

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Pall® Breathing Circuit Filter - 00636207000248 Catalog Number : BB50T

Device Description : Bi-directional bacterial/viral removal filter. Indicated for use on ventilators, Bi-directional bacterial/viral removal filter. Indicated for use on ventilators, water bath humidifiers and other medical gas equipment where the gas outlet fitting complies to ISO 5356-1 for the protection of the patient, staff, equipment and environment. Provides greater than 99.999% bacterial and viral efficiency.

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Pall Posidyne® ELD Filter - 00636207000323 Catalog Number : ELD96LL

Device Description : 0.2 micron Intravenous Filter for 96 Hour Use with Micro-bore Extension Tubing a 0.2 micron Intravenous Filter for 96 Hour Use with Micro-bore Extension Tubing an Luer-Lock Adapter

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall Posidyne® ELD Filter - 00636207000330 Catalog Number : ELD96LYL

Device Description : 0.2 micron Intravenous Filter for 96 Hour Use with Micro-bore Extension Tubing, 0.2 micron Intravenous Filter for 96 Hour Use with Micro-bore Extension Tubing, Y injection site and luer lock adapter

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall Posidyne® ELD Filter - 00636207000347 Catalog Number : ELD96LYLS

Device Description : 0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubin 0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing, Y injection site and luer lock adapter

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall® Total Nutrient Admixture Filter - 00636207000699 Catalog Number : TNA1

Device Description : 1.2 micron Total Nutrient Admixture Filter with Non-Phthalate Fluid Pathway

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Pall Ultipor™ 100 Breathing System Filter - 00636207000743 Catalog Number : BB100A

Device Description : Ultipor 100 Breathing System Filter indicated to provide heat, humidity, bacteri Ultipor 100 Breathing System Filter indicated to provide heat, humidity, bacterial and viral removal (99.999%) with mechanical ventilation and circle anesthesia.

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Pall Ultipor™ 100 Breathing System Filter - 00636207300683 Catalog Number : BB100AF

Device Description : Ultipor 100 Breathing System Filter with Flex Tube and Monitoring Port. Provides Ultipor 100 Breathing System Filter with Flex Tube and Monitoring Port. Provides heat, humidity, bacterial and viral removal (99.999%) with mechanical ventilation and circle anesthesia.

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Pall Ultipor™ 100 Breathing System Filter - 00636207300690 Catalog Number : BB100APF

Device Description : Ultipor 100 Breathing System Filter with Monitoring Port and Flex Tube. High eff Ultipor 100 Breathing System Filter with Monitoring Port and Flex Tube. High efficiency bacterial/viral filter and HME for patient end use with mechanical ventilation and circle anesthesia.

Device Class : 2

Duns Number: 002054419

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

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