FDA.reportPublic FDA data

INTERSURGICAL, INC.

Matched from indexed company URL: Intersurgical Incorporated

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13194471000120301INTERSURGICAL, INC.1Y2026-01-015010 Campuswood Dr, Ste 102 East Syracuse NY US 13057
30107413663010741366INTERSURGICAL S.P.A.1N2026-01-01Via Tonino Morandi, 12 Mirandola (MO) Italy Modena IT 41037
30115032273011503227Intersurgical Medical Sdn. Bhd.1N2026-01-01993,Lorong Perindustrian Bukit Minyak 11 Taman Perindustrian Bukit Minyak Simpang Ampat Pulau Pinang MY 14100
30151688433015168843INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.1N2026-01-01No. 1011, Liaohe Road, Xinbei District Changzhou City Jiangsu CN 213125
30028072853002807285INTERSURGICAL LIMITED-GUERNSEY1N2020-04-25CIRCUIT HOUSE, PITRONNERIE RD ST. PETER PORT Not Applicable GG GY1 2RL

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05030267056057Y-PIECE 22M, 22M, 22M/15F - 19000003154512900support@intersurgicalinc.com
05030267056095Y-PIECE 22M, 22M, 22M/15F WITH PORTS - 19010003154512900support@intersurgicalinc.com
05030267056118Y-PIECE 15M, 15M, 15F - 19020003154512900support@intersurgicalinc.com
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE - 1997000S+3154512900support@intersurgicalinc.com
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER - SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER AND TUBE, 2.1M USA+3154512900support@intersurgicalinc.com
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY - 1141035+3154512900support@intersurgicalinc.com
05030267169597SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER - SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M USA+3154512900support@intersurgicalinc.com
05030267169634SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO MONITORING LINE AND TUBE - SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE AND TUBE, 2.1M USA ONLY+3154512900support@intersurgicalinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
184161071035587K990949CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORTCAH1999-06-15
438091309145588K990949CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORTCAH1999-06-15
438091143949102K984481EXHALATION VALVECBP1999-01-29
184161397905368K983610CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18CAH1999-04-30
438091550720567K983610CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18CAH1999-04-30
438091725090096K925462BREATHING FILTERS 1942T/1941T/2014TCAH1993-05-21
438091321678729K911427BREATHING FILTERSCAH1991-08-26
438091890096860K911422DRUG NEBULIZERSCAF1991-10-23
438091268271908K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleCCK2015-02-13
438091324203356K141087INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEFCAH2015-02-12
438091552184654K132143EXHALATION VALVECBP2014-06-04
438091064566255K122077MANOMETERCAP2013-01-10
438091115905201K122075DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTERCCK2012-12-20
438091614559111K121747FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKSBZD2013-03-14
438091553889290K121026FLO-GUARD BREATHING FILTERCAH2012-11-02
438091651928058K120463MOJO, VERASEALBZD2012-07-27
438091297319500K092451INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTERCAH2010-10-29
438091143187182K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTERCAH2010-03-10
438091739217657K092129INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330BZE2010-05-18
438092014608193K063806SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTEDCBK2007-05-17
438091741175260K032322CLEAR-THERM MICRO HME, MODEL 1441CAH2004-05-13
438091655709100K031794ENDOFLEX TRACHEAL TUBEBTR2004-03-12
184161506874090K024270CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3CAH2003-06-24
438091507898033K024270CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3CAH2003-06-24
1781331739912801K003497DISPOSABLE PRESSURE MONITORCAP2000-11-30
438091035252125
438091041820371
438091059261830
438091071409187
438091093624485
438091096921981
438091128857139
438091141409931
438091163805480
438091191875301
438091276127909
438091300495708
438091343688866
438091364601700
438091463140202
438091506654013
438091590969958
438091620957185
438091623350487
438091660507650
184161688568795
438091689373665
438091703787537
438091728816956
438091816999195
438091863046570
438091896887353
184161910464117
438091949760345
438092056230386
438091058100525
2266941081668813
2266941133864342
438091162148333
1781331201341697
438091213900787
2788031222225552
2266941265428572
2266941303079836
438091342210484
2266941390907258
2266941434069489
1781331495180536
2788031562438414
2266941607277593
2266941618524206
2266941619352806
2788031627588453
2266941642732573
2266941662379337
438091716147519
1781331777376622
2266941797296589
1781331815786154
2266941920521897
438091943424309
2266941955770217
1781331977011551
438091980642000
438092000172079
1781332070334142

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAH132015-02-12
CCK32015-02-13
CBP22014-06-04
BZD22013-03-14
CAP22013-01-10
BZE12010-05-18
CBK12007-05-17
BTR12004-03-12
CAF11991-10-23

PMN#

GUDID#

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