FDA Registration
Active
🇬🇧 United Kingdom
GVS Filter Technology UK Ltd
Reg #: 3004428458
·
FEI: 3004428458
·
Expires 2026
Products
12
Proprietary Names
161
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- GVS Filter Technology UK Ltd
- Registration Number
- 3004428458
- FEI Number
- 3004428458
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Caton Road
- City
- Lancaster Lancashire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K040712
Owner / Operator
- Firm Name
- GVS Filter Technology UK Ltd.
- Operator Number
- 9098065
- Address
- Caton Road
- City
- Lancaster
- State
- GB-NOTA
- Postal Code
- LA1 3PE
- Country
- GB
- Correspondent
- Andrew Pearce
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr. NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sv70 Ventilator | MNT | Class 2 | Anesthesiology | No | 2023-12-20 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2023-12-20 |
| Accessory To Continuous Ventilator (Respirator) | MOD | Class 2 | Anesthesiology | No | 2007-02-26 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2024-07-30 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2007-02-26 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2023-12-20 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2014-06-05 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2007-03-07 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2023-12-20 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2023-12-20 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2014-06-05 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2007-02-26 |
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
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
7273/620AOUA008/0050
R390-7494
Air 11 Filter, STD
R390-7495
7272/629AOUA008/0050
7271/343AJUA008/1800
R330-776
S8/ Type A Hypo Filters
7271/409AJUB008/1800
S8/Type A STD Filter
R330-733
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device