Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008412416

FEI Number

3008412416

Entity Name

Pall International, Sarl

City/State/Country

Fribourg, CH

Establishment Address

Ave de Tivoli 3, Fribourg 1700, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Pall Medical (Owner Number: 2410597)

Owner / Operator Contact Address

C/O Global Life Sciences Solutions USA LLC, 100 Results Way, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K854062

PMA Number

N/A

All Registered Proprietary Names

Pall Posidyne ELD Posidyne NEO Filter Set Pall Posidyne ELD 0.2 micron Intravenous Filter PharmAssure Vent Filter Transducer Protector; 25 mm Vent Filter Gardian 25mm Syringe Filter Medtronic ATBAG600 Medtronic ATBAG1000 Medtronic ATBAG300 Total Nutrient Admixture Filter TNA Total Nutrient Admixture Filter TNA1 Pall-Aquasafe Water Filter Oxygenator Gas Line Filter Ultipor 100 Breathing System Filter with Flex Tube Conserve Small Volume HME Filter Ultipor 100 Breathing System Filter with CO2 Monitoring Port Ultipor Breathing Circuit Filter Ultipor 100 Breathing System Filter Thermogenesis Transfer/Freezing Bag Set Transfer/Freezing Bag Set Pall Syringe Filter PharmAssure Syringe Filter Pall QPoint Water Filter Capsule Pall QPoint Disposable Water Filter Qpoint Docking Station Shower Qpoint Docking Station Tap Freezing Bag Thermogenesis Freezing Bag Pro-Tec Pulmonary Function Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	1994-03-30
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2011-03-17
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2013-01-31
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	1994-03-30
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2016-07-12
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2016-03-17
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	1999-02-18
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2003-08-29
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2017-07-07
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2010-05-14

Official Correspondent

No official correspondent registered.

US Agent Details

Lois Ostringer Business: Global Life Sciences Solutions USA LLC Email: Lois.Ostringer@cytiva.com Phone: (516) 4741679

Related Public Records

Same Entity

Pall Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2647898	PALL LIFE SCIENCES PUERTO RICO, LLC	Fajardo, PR, US
9680602	PALL NEWQUAY	Newquay Cornwall, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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1422078	DOUGLAS MEDICAL PRODUCTS, INC	Mundelein, IL, US
1319639	Sterigenics U.S., LLC	Queensbury, NY, US
3015276780	TAM VIET DISTRIBUTION COMPANY LIMITED	HO CHI MINH, VN
3008132398	Sterigenics UK Limited	Alfreton Derbyshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008412416. Last updated year: 2026. Please use registration number 3008412416 when referencing this establishment in official correspondence.