ORIDION MEDICAL 1987 LTD.

FDA Device Registration & Listing · JERUSALEM, IL · Registration 8044004

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8044004
FEI Number
3001227743
Entity Name
ORIDION MEDICAL 1987 LTD.
City/State/Country
JERUSALEM, IL
Establishment Address
7 HAMARPE ST. P.O. BOX 45025, JERUSALEM 9777407, IL
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Covidien llc (Owner Number: 1282497)
Owner / Operator Contact Address
15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MAC-Line O2/CO2 Oral Nasal Cannula Sample Line MAC-Line Oral Nasal Cannula Sample Line Carinal VitaLine Set CARESCAPE CO2 Microstream parameter BIS™ Advance Monitoring System Microstream Advance Pediatric Oral- Nasal, with O2 tubing, short-term Microstream Advance Adult Bite Block, short-term Microstream Advance Pediatric Oral- Nasal, short-term Microstream Advance Pediatric Nasal, with O2 tubing, short-term Microstream Advance Adult Nasal, with O2 tubing, 4m, short-term MIcrostream Luer Adult Nasal, with O2 tubing, short-term Microstream Advance Pediatric Nasal, short-term Microstream Advance Adult Nasal, short-term MIcrostream Luer Pediatric Oral-Nasal, with O2, short-term Microstream Luer Adult Oral-Nasal Sampling Line Microstream Advance Adult Oral Nasal CO2 Filter Line with O2 Tubing, extended duration Microstream Advance Pediatric Oral-Nasal FilterLine with O2 Tubing MIcrostream Luer Pediatric Nasal, with O2 tubing, short-term Microstream Advance Adult Oral-Nasal, with O2 connector, 4m, short-term Microstream Advance Adult Oral-Nasal FilterLine with O2 tubing Microstream Advance Neonatal-Infant Nasal FilterLIne with O2 Tubing MIcrostream Luer Adult Oral-Nasal, with O2 tubing, short-term Microstream Advance Pediatric Oral-Nasal, 4m, with O2 tubing, short-term Microstream Advance Adult Oral Nasal CO2 Filter Line with O2 Tubing, 4M, extended duration Microstream Advance Adult Bite Block, with O2 tubing, 4M, short-term Microstream Advance Adult Oral-Nasal, with O2 connector Microstream Luer Adult Bite Block, with O2 tubing, 4M, short-term Microstream Advance Adult Oral-Nasal, 4m, with O2 tubing, short-term Microstream Luer Adult Bite Block, with O2 tubing, short-term Microstream Advance Adult Bite Block, with O2 tubing, short-term Microstream Advance Adult Nasal, with O2 Tubing, short term Microstream Advance Adult Oral-Nasal, with O2 tubing, short-term MAC-Line O2/CO2 Nasal Cannula Sample Line Microstream Oral Nasal Cannula FilterLine BIS Sensor Simulator Capnostream20p FilterLine H (FilterLine ICU) Microstream Filterline Nasal Cannula MAC-Line CO2 Nasal Cannula Sample Line PM35MN02-RR PM35MN01-RR PM35MN05-RR Capnostream35 Portable Respiratory Monitor Microstream O2/CO2 Oral Nasal Filterline O2/CO2 Nasal FilterLine Vista, BISx, BISx4 Airway adapter Microstream Luer Adult-Pediatric Intubated Sampling Line Microstream Luer, short-term Microstream Advance Adult-Pediatric, Intubated, 4m, Long term Microstream Advance Intubated, short-term Microstream Advance Adult-Pediatric Intubated FilterLine Microstream Advance Adult-Pediatric Intubated, High-humidity Microstream Advance Adult-Pediatric Intubated, short-term Advance Adult-Pediatric Intubated, 4M, short-term Microstream CO2 NanoPod Microstream™ Nihon Kohden CO2 NanoPod Hook and Loop Strap

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-04-26
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2024-03-14
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2024-03-14
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2024-03-14
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2024-03-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2019-11-03
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2017-02-01
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2015-11-18
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2015-11-18
DQA Oximeter Cardiovascular Class 2 870.2700 2015-11-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-08-17
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2020-08-17
DQA Oximeter Cardiovascular Class 2 870.2700 2020-08-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-02-25
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2009-12-04
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2009-12-04
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2009-12-04
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2009-12-04
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2009-04-02
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2019-11-03
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-08-03
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2016-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Business: Covidien Email: kae.miller@medtronic.com Phone: (303) 4081427

Related Public Records

Same Entity

Covidien llc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8020889 Mallinckrodt Medical ATHLONE Westmeath, IE
3006451981 Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai, CN
1282497 Covidien LLC MANSFIELD, MA, US
9681384 Covidien Ciudad Juarez Chihuahua, MX
2024500 COVIDIEN CARLSBAD, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
K033010 Brainz Instruments , Ltd. BRM2 BRAIN MONITOR 2003-10-10
K991012 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY EEG POD 1999-06-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
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
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659
Z-0030-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M TO MASIMO, Part Number CS08750
Z-0031-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
Z-0032-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) N REFURBISHED, Part Number CS78651
Z-0033-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US)M REFURBISHED, Part Number CS78653
Z-0034-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
Z-0035-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
Z-0036-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (INTL) N, Part Number CS08652
Z-0037-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
Z-0038-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
Z-0039-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
Z-0040-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
Z-0041-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
Z-0042-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
Z-0043-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
Z-0044-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (INTL) M, CS08654

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044004. Last updated year: 2026. Please use registration number 8044004 when referencing this establishment in official correspondence.
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