FDA Registration
Active
🇱🇹 Lithuania
UAB INTERSURGICAL
Reg #: 3001313714
·
FEI: 3002807293
·
Expires 2026
Products
24
Proprietary Names
88
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- UAB INTERSURGICAL
- Registration Number
- 3001313714
- FEI Number
- 3002807293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ARNIONIU g. 60
- City
- PABRADE Svencionys
- Country
- LT
Regulatory Submissions
- 510(k) Number
- K925462
Owner / Operator
- Firm Name
- INTERSURGICAL UAB
- Operator Number
- 9058058
- Address
- ARNIONIU g. 60, --
- City
- PABRADE
- State
- LT-NOTA
- Postal Code
- LT-18170
- Country
- LT
- Correspondent
- Ivan Seniut
US Agent
- Business Name
- Intersurgical Inc
- Contact Name
- Kerrie Campbell
- Address
- 5010 Campuswood Dr, Ste 102
- City
- East Syracuse
- State
- NY
- ZIP
- 13057
- Country
- US
- [email protected]
- Phone
- 315 4512900 ext. 500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2012-04-26 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2021-10-25 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2003-08-14 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2007-11-12 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2022-05-25 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2014-06-05 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2020-11-13 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2003-08-14 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2010-05-19 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2010-05-19 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2021-09-15 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2003-08-14 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2003-08-14 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2012-07-26 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2003-08-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-06-15 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2012-01-03 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2014-07-29 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2003-08-14 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2003-08-14 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2007-11-12 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2003-08-14 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2003-08-14 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2011-09-19 |
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
8903030, 8904030, 8905030
8003001, 8003002, 8004001, 8004002, 8005001, 8005002
8201000, 8202000, 8203000, 8204000, 8205000, 8215000, 8225000, 8603000, 8604000, 8605000
airway support strap, 8800000
8001000, 8001002, 8002000, 8002001, 8002002, 8003000, 8003003, 8003050, 8004000
Guedel airway, Layrngeal Mask Airway, Solus Flexible
i gel Supraglottic Airway, i gel plus Supraglottic Airway, i-gel O2 Resus Pack
8004003, 8004050, 8005000, 8005003, 8005050, 8015000, 8015002
8703030, 8704030, 8705030
1000035, 1100050, 1110055, 1111065, 1111570, 1112080, 1113090, 1114100, 1115120
i-gel Plus Resus Pack, 8803030, 8804030, 8805030
8025000, 8025001, 8025002
i-gel Plus anaesthesia, 8903000, 8904000, 8905000
8210030, 8265030, 8275030, 8285030
1402000, 1402004, 1453013, 1453015, 1454013, 1454015, 1455000, 1455001
1453014, 1454017, 1455002
1503000, 1402018, 1417000
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
1165013, 1165005, 1164000
i-flo high flow nasal cannula, 7300000, 7301000, 7302000, 7300001, 7301001, 7302001
Clearlite Masks,7290000, 7291000, 7292000, 7293000, 7294000, 7295000, 7296000
ClearLite anesthetic face mask NO hook ring, 7292001, 7293001, 7295001
ClearLite Air anesthetic face Masks, 7394000, 7394001
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device