Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001313714

FEI Number

3002807293

Entity Name

UAB INTERSURGICAL

City/State/Country

PABRADE Svencionys, LT

Establishment Address

ARNIONIU g. 60, PABRADE Svencionys LT-18170, LT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INTERSURGICAL UAB (Owner Number: 9058058)

Owner / Operator Contact Address

ARNIONIU g. 60, --, PABRADE, LT-NOTA LT-18170, LT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

2820000, 2830000 1107085, 1117015, 1118005, 1137015, 1138015, 1139000 1024085, 1028085, 1031085, 1035085, 1040085, 1060085 Venturi Mask, Venturi Valve 1400024, 1400028, 1400031, 1400035, 1400040, 1400050, 1400060 Clear-Therm Micro HMEF, 1441000 1435000, Nose clip-foam pads Exhalation Valves, 5191000, 5113018, 5182000, 5183000, 5183010 One-way valve, 1953000, 1921000 Adult Water Trap, 1911000, 1912000, 1915000, 1916000 2026030, 2026035 2310000 2026310, 2026000, 2060310, 5025000, 5025310, 5026000 5191850, 5194850 Universal Stylet Bougie, 8090015, 8080015 1477003, 1930000, 1931000, 1937000, 1938000 3501000 1983000, 1984000, 1985000, 1986000, 1988000, 1989000, 1991000 1960000, 1961000, 1962000, 1963000, 1964000, 1964001, 1965000 1966000, 1966001, 1967000, 1968000, 1969000, 1970000, 1971000 1943000, 1947001, 1947003, 1948000, 1949000, 1959000, 3504000S, 1660000, 0556030 3505000, 3506000, 3514000, 3516000, 3521000, 3532000, 5802801, 5802802, 5807000 1568000, 1661000, 1663000, 1664000, 1701000, 1702000, 1703000, 1704000 2710000, 2712000, 2713000, 2714000, 9747000, 1947000, 1948000, 3520000 1974000, 1975000, 1978000, 1979000, 1980000, 1981000, 1982000 1705000, 1706000, 1800000, 1802000, 1891000, 1893000, 1897000, 1898000 Double swivel elbow, 1899000 1900000, 1901000, 1902000, 1903000, 1926000, 1927000, 1929000, 1933000 1990000, 1992000, 1993001, 1993000, 1995000, 1997000, 1997000S Superset double swivel elbow catheter mount, 3512000 Inter-Therm HMEF & Inter-Guard Filter 1344000S, 1344007S, 1344711S 1341000S, 1341007S, 1341011S, 1341580S 1174010 Tube management clip system, 2314000, 2315000, 2316000, 2317000, 2318000, 2319000 One way valve, 1950000, 1952000, 1954000 Straight connector, 1945000, 1946000 Clear-Guard 3, 1545000 Clear-Therm 3 HMEF with and without luer port and retainable cap, 1541000 Clear-Therm Mini HMEF, 1831000 Oxygen Mask, Sentri Intersurgical EcoLite Mask, Tracheostomy Mask, Aerosol mask, Economy Mask 1145000, 1188015, 1190015, 1196015, 1198015, 1200050 1181015, 1181017 1135015, 1136015, 1141035 1135017, 1137016, 1196019, 1206000, 1137016 Flo-Guard, 1690000 1142035, 1143035, 1143038 2734100 1144015, 1144016, 1144017 Inter-Therm Mini Pediatric HMEF, 1331000S, 1332000S TNI Clear-Guard3 angled breathing filter OroCare suction control valve flexible, flexible connector 3024000 OroCare suction control valve flexible, stepped connector 3023000 Hydro-Guard & Air-Guard Breathing Filters, 1745000, 1745002, DYNJAAHF, 1745801, 1790000 1442000, 1850000, 1855000, 1873000, 1874000 Hydro-Therm Micro HME, Hydro-Therm HME 1875000, 1875001, 1875020, 1875000S, 1875001S, 1875020S Hydro-Trach T Mk II HME, Inter-Therm T+ HME, Inter-Therm T HME

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2012-04-26
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2021-10-25
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2003-08-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2022-05-25
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2014-06-05
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2020-11-13
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2003-08-14
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2010-05-19
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2010-05-19
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2021-09-15
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2003-08-14
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2003-08-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2010-11-08
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2003-08-14
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2012-07-26
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2020-11-13
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-05-05
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2003-08-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2013-04-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-06-15
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2012-01-03
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2015-02-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-06-20
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2014-07-29
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2011-05-03
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2003-08-14

Official Correspondent

Ivan Seniut

US Agent Details

Kerrie Campbell Business: Intersurgical Inc Email: kcampbell@intersurgicalinc.com Phone: (315) 4512900

Related Public Records

Same Entity

INTERSURGICAL UAB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021039857	UAB Intersurgical	Visaginas Salcininkai, LT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001313714. Last updated year: 2026. Please use registration number 3001313714 when referencing this establishment in official correspondence.