Global Life Sciences Solutions USA LLC

FDA Device Registration & Listing · Marlborough, MA, US · Registration 3012821221

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012821221
FEI Number
3012821221
Entity Name
Global Life Sciences Solutions USA LLC
City/State/Country
Marlborough, MA, US
Establishment Address
100 Results Way, Marlborough, MA 01752, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Global Life Sciences Solutions USA LLC (Owner Number: 1831947)
Owner / Operator Contact Address
25 Harbor Park Drive, Port Washington, NY 11050, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K993379
PMA Number
N/A

All Registered Proprietary Names

LaparoShield Laparoscopic Smoke Filter; LaparoShield Plus Laparoscopic Smoke Filter Pall-Aquasafe Water Filter Pall QPoint™ Disposable Water Filter; Pall QPoint™ Water Filter Capsule Pro-Tec Pulmonary Function Filter Medtronic ATBAG1000; Medtronic ATBAG300; Medtronic ATBAG600 Pall Syringe Filter; PharmAssure Syringe Filter Thermogenesis Transfer/Freezing Bag Set; Transfer/Freezing Bag Set oxygenator gas line filter Gardian 25mm Syringe Filter Freezing Bag; Thermogenesis Freezing Bag Total Nutrient Admixture Filter TNA; Total Nutrient Admixture Filter TNA1 Oxygenator Gas Line Filter SUPOR; SUPOR AEF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-04-05
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2023-04-05
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2023-04-05
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2023-04-05
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2023-04-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-04-05
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2023-04-05
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2024-04-02
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2023-04-05
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2023-04-05
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2023-04-05
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2023-04-05
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2023-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Global Life Sciences Solutions USA LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K923989 Sensor Medics Corp. SENSORMEDICS MODEL 6200 AUTOBOX DL 1993-08-09
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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012821221. Last updated year: 2026. Please use registration number 3012821221 when referencing this establishment in official correspondence.
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