FDA Registration
Active
🇬🇧 United Kingdom
PALL NEWQUAY
Reg #: 9680602
·
FEI: 1000268645
·
Expires 2026
Products
9
Proprietary Names
57
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- PALL NEWQUAY
- Registration Number
- 9680602
- FEI Number
- 1000268645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ST. COLUMB MAJOR
- City
- Newquay Cornwall
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K941589
Owner / Operator
- Firm Name
- Pall Medical
- Operator Number
- 2410597
- Address
- C/O Global Life Sciences Solutions USA LLC, 100 Results Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
US Agent
- Business Name
- Pall Medical
- Contact Name
- Lois Ostringer
- Address
- 100 Results Way
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 516 8019299
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2003-08-29 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2011-03-17 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2007-12-19 |
| System, Water Purification, General Medical Use | NHV | Class 2 | Gastroenterology, Urology | No | 2016-07-12 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 1999-02-18 |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | Class 2 | Hematology | No | 2012-02-27 |
| Cord Blood Processing System And Storage Container | OAO | Class 2 | Hematology | No | 2016-07-12 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2010-05-14 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2016-03-17 |
Proprietary Names
Pall Syringe Filter
PharmAssure Syringe Filter
PharmAssure Vent Filter
Transducer Protector; 25 mm Vent Filter
LaparoShield Plus Laparoscopic Smoke Filter
LaparoShield Plus Laparoscopic Smoke Filtration System
Gardian 25mm Syringe Filter
Pall-Aquasafe Water 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
Ultipor U55 Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger
Freezing Bag
Thermogenesis Freezing Bag
Briostor Transfer/Freezing bag set
Expandable Flex Tube 15 mm X 5"
Anesthesia Breathing Circuit - Breathing Bag 2L
Anesthesia Breathing Circuit - Adult Machine Kit 96 2Lbag NCO2
Patient Kit - Adult Mask Medium
Patient Kit - Pediatric Mask
Anesthesia Breathing Circuit - Adult Kit 40 Coax
Anesthesia Breathing Circuit - Ped Machine Kit 96
Anesthesia Breathing Circuit - Adult Kit 60 Coax
Pall Ultipor 25 Filter
Patient Kit - Adult Mask Large
Anesthesia Breathing Circuit - Expandable dual 40
CO2 Gas Sampling line
Patient Kit - Adult Mask Extra (Ultra) large
Anesthesia Breathing Circuit - Adult Machine Kit 96 2Lbag
Elbow
Anesthesia Breathing Circuit - Adult Kit 72 Nonexp
Anesthesia Breathing Circuit - Adult Kit 72 Coax
Anesthesia Breathing Circuit - Ped Kit 72 Coax
Patient Kit - Adult Mask Small
Anesthesia Breathing Circuit - Breathing Bag 3L
Anesthesia Breathing Circuit - Adult Machine Kit 96 3Lbag
Medtronic ATBAG600
Medtronic ATBAG1000
Medtronic ATBAG300
Thermogenesis Transfer/Freezing Bag Set
Transfer/Freezing Bag Set
Cell Wash/Infusion Bag
Pro-Tec Pulmonary Function Filter
Total Nutrient Admixture Filter TNA
Total Nutrient Admixture Filter TNA1
Pall QPoint Water Filter Capsule
Pall QPoint Disposable Water Filter
Qpoint Docking Station Shower
Qpoint Docking Station Tap
SUPOR
SUPOR AEF
Oxygenator Gas Line Filter
Pall Posidyne ELD
Posidyne NEO Filter Set
Pall Posidyne ELD 0.2 micron Intravenous Filter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device