Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021039857

FEI Number

3021039857

Entity Name

UAB Intersurgical

City/State/Country

Visaginas Salcininkai, LT

Establishment Address

Duksto kelias 84 A, Visaginas Salcininkai LT-31146, 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

Adult Water Trap, 1911000, 1912000, 1915000, 1916000 Exhalation Valves, 5191000, 5113018, 5182000, 5183000, 5183010 5805009 2010257, 2010258, 2920010, 2920310 1573000, 1574000, 2000058, 2900000, 2901000, 2902000, 2903000, 2930000, 2300000 Smoothbore bilevel breathing system, 5005000, 5018000, 5018011, 5118001, 5804000, 5805000 4510000 5805030, 5805031, 5018000S, 2121000, 2142000, 2010000 Compact breathing system, Flextube breathing system, Mapleson breathing system 2000000, 2158000 UniFlow and DuoFlow breathing systems 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 1165013, 1165005, 1164000 i-flo high flow nasal cannula, 7300000, 7301000, 7302000, 7300001, 7301001, 7302001 2026030, 2026035 2310000 2026310, 2026000, 2060310, 5025000, 5025310, 5026000 5191850, 5194850

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2003-08-14
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2014-06-05
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2023-01-16
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2003-08-14
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2003-08-14
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	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

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
3001313714	UAB INTERSURGICAL	PABRADE Svencionys, LT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021039857. Last updated year: 2026. Please use registration number 3021039857 when referencing this establishment in official correspondence.