FDA.reportPublic FDA data

ORIDION MEDICAL 1987 LTD.

Matched from indexed company URL: ORIDION MEDICAL LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80440043001227743ORIDION MEDICAL 1987 LTD.1N2026-01-017 HAMARPE ST. P.O. BOX 45025 JERUSALEM IL 9777407

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
10884521552104Microstream - MICROSTREAM SMART CAPNOLINE GUARDIAN, 1 UN+1(508)261-8000covidien.udi@covidien.com
20884521551906Microstream - ORIDION: SMART CAPNOLINE PLUS O2 ADULT/INT+1(508)261-8000covidien.udi@covidien.com
20884521551999Microstream - FILTERLINE H SET ADULT/PEDIATRIC+1(508)261-8000Covidien.UDI@covidien.com
20884521761787Microstream Advance - Neonatal-Infant Nasal CO2 Filter Line; Extended Duration+1(508)261-8000covidien.udi@covidien.com
20884521761794Microstream Advance - Neonatal-Infant Nasal CO2 Filter Line; Extended Duration+1(508)261-8000covidien.udi@covidien.com
20884521761800Microstream Advance - Neonatal-Infant Nasal CO2 Filter Line with O2 Tubing; Extended Duration+1(508)261-8000covidien.udi@covidien.com
20884521761824Microstream Advance - Adult Nasal CO2 Filter Line with O2 Tubing; Extended Duration+1(508)261-8000covidien.udi@covidien.com
20884521771731Microstream Advance - Neonatal-Infant Nasal CO2 Filter Line; Short-term use: Procedural/Emergency+1(508)261-8000covidien.udi@covidien.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
452331043247324K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
452331350882433K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
452331225192739K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
452332030213928K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
452331040328427K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
452331064077375K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
452331701971253K230693BIS™ Advance Monitoring SystemOLW2024-02-26
452331332781116K213911Microstream CO2 NanoPodCCK2022-07-29
452331854091739K213518CARESCAPE CO2 Microstream parameterCCK2022-04-12
452331131392038K200594Capnostream 35 Portable Respiratory MonitorCCK2020-04-27
452331741329202K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineCCK2019-03-22
452331639415304K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineCCK2019-02-08
452331755861529K150272Capnostream 35 Portable Respiratory MonitorCCK2015-07-17
452331818637143K143506BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)GXY2015-04-16
452331474717600K123690CAPNOSTREAM20P WITH HIFI C02 MONITORINGCCK2014-08-05
452331724025104K121927MICROSTREAM FILTERLINE ICUCCK2012-11-29
452331739774436K121927MICROSTREAM FILTERLINE ICUCCK2012-11-29
452331769463335K112368CAPNOSTREAM20P WITH AI/ODICCK2012-07-19
452331526028328K094012CAPNOSTREAM20 WITH MICROMEDICO2 MODULECCK2010-05-12
452331185709834K093388SMART CAPNOLINE GUARDIANCCK2010-03-04
452331210280950K093388SMART CAPNOLINE GUARDIANCCK2010-03-04
452331451692542K082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEXDQA2009-02-06
452331005115521K072295CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWAREDQA2007-10-11
452331203101264K072286BIS EEG VISTA MONITOR SYSTEM AND BISXOLW2007-11-20
452331203840460K060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITORDQA2006-05-04
452331419666754K042665SMART BITEBLOCCCK2004-11-23
452332045988429K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINECCK2001-11-29
452332046298608K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINECCK2001-11-29
452331028429954K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331146082176K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331086954347K012394ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINECCK2001-08-15
452331923950138K012394ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINECCK2001-08-15
452331024457092K012391MAC-LINE CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331789199494K012391MAC-LINE CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15
452331285625041K011536MICROSTREAM O2/CO2 ORAL NASAL FILTERLINECCK2001-11-14
452331643219718K011536MICROSTREAM O2/CO2 ORAL NASAL FILTERLINECCK2001-11-14
452331466793430K011050MICROSTREAM ORAL NASAL CANNULA FILTERLINECCK2001-05-04
452332070118951K011050MICROSTREAM ORAL NASAL CANNULA FILTERLINECCK2001-05-04
452331676338625K010024O2/CO2 NASAL FILTERLINECCK2001-03-14
452332069244467K010024O2/CO2 NASAL FILTERLINECCK2001-03-14
452331884538529K002163MICROSTREAM EXTERNAL BATTERY CHARGERCCK2001-01-11
452331395916702
452331078884436
452331463292085
452331572336384
452331977569441

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CCK362022-07-29
DQA32009-02-06
OLW22024-02-26
GXY12015-04-16

PMN#

GUDID#

80 records. Showing 1-40. Next