Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004428458

FEI Number

3004428458

Entity Name

GVS Filter Technology UK Ltd

City/State/Country

Lancaster Lancashire, GB

Establishment Address

Caton Road, Lancaster Lancashire LA1 3PE, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

GVS Filter Technology UK Ltd. (Owner Number: 9098065)

Owner / Operator Contact Address

Caton Road, Lancaster, GB-NOTA LA1 3PE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051712

PMA Number

N/A

All Registered Proprietary Names

Stellar Hypoallergenic Filter R241-7019 7274/422APUA008/0006 R360-7253 7272/401AOUB008/0050 S9/ Air10 Filter, Hypo R360-7254 7273/519AOUB008/0050 3800 3900 3400 VENTILATOR INLET FILTER 3700 3500 in line filter 2200/47BDKBTUA123/0001 2200/72BTUA123/0001 9777 1420 2000 8444 DYNJAAHME11 DYNJAAHMEHEPA DYNJAAHME13 DYNJAPHME17 DYNJAAHME1 DYNJAAHME9 DYNJAPHME19 DYNJAAHME5 DYNJAAHEPA VIRAL FILTER 7275 BACTERIAL 7274 7273 7272 7271 Suction Filter 2200 4444 9041 4220 4100 6800 4244 4331 3200 9065 6200 5600 7000 5100 8866 9066 3888 4333 8222 6888 9070 5500 9064 9500 9071 6500 4222 9200 4020 9085 8877 9040 9898 5200 9800 4000 9080 9600 7270 300 3000 R380-7924 7273/575AOUB008/0050 Air Mini Filter 7272/591AOUA008/0050 R380-7855 A508 HME PAD DYNJAPHME20 DYNJAAHME2 DYNJAPHME10 DYNJAPHME18 DYNJAAHME8 DYNJAPHME22 DYNJAAHME10 DYNJAAHME14 DYNJAAHME6 DYNJAAHME24 DYNJAPHME23 DYNJAAHME12 9064/M/752 9065/M/750 8866/M/750 9064/751+a620/60/61 9080/M/750 9066/M/751 9500/710 4333/M/752 9067/M/750 9065/750+a620/60/61 4333/M/751 9064/M/751 9085/M/751 9064/751 6201/51 9085/751 4333/754 9066/751 1460/05 9066/50 9064/750 9067/750 8866/50 9065/750 4333/751 6200/50 1460/06 9080/750 6200/51 6201/50 9500 4331/50 4333/50 4333/752 4333/750 9066/750 9085/01 Press Sense Filter - Astral R270-719 7274/489AOUA008/0050 R270-7139 Inlet Filter Pack - Astral 6421/04 6421/04BPK Insufflation Kit 2200/48BIKBTUA123/0001 Insufflation Set 2200/65 1600 Hands-Free oscillometry kit PULMONARY FUNCTION TESTING FILTER 2800 2801 100 2800/22DKKBAUA127/0001 PFT Filters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2023-12-20
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-12-20
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2007-02-26
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2024-07-30
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-02-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-12-20
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2023-12-20
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2014-06-05
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2007-03-07
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2023-12-20
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-12-20
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2014-06-05
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2007-02-26

Official Correspondent

Andrew Pearce

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

GVS Filter Technology UK Ltd.

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
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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3010817335	BREAS MEDICAL, INC.	N Billerica, MA, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004428458. Last updated year: 2026. Please use registration number 3004428458 when referencing this establishment in official correspondence.