| Primary Device ID | 10884521761858 |
| NIH Device Record Key | fa9cdca4-30c2-45aa-a930-c823b657a06b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microstream Advance |
| Version Model Number | MVANOL |
| Catalog Number | MVANOL |
| Company DUNS | 600111512 |
| Company Name | ORIDION MEDICAL 1987 LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
| Length | 4 Meter |
| Device Size Text, specify | 0 |
| Length | 4 Meter |
| Device Size Text, specify | 0 |
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| Length | 4 Meter |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521761858 [Package] Contains: 20884521761855 Package: CASE [25 Units] In Commercial Distribution |
| GS1 | 20884521761855 [Primary] |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-17 |
| Device Publish Date | 2020-01-09 |
| 40884521520746 | Hook and Loop Strap |
| 10884521771758 | Pediatric Nasal CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521771741 | Adult Nasal CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521762015 | Neonatal-Infant Intubated CO2 Filter Line; High Humidity |
| 10884521762008 | Adult-Pediatric Intubated CO2 Filter Line; High Humidity |
| 10884521761995 | Neonatal-Infant Intubated CO2 Filter Line; Extended Duration |
| 10884521761988 | Neonatal-Infant Intubated CO2 Filter Line; Extended Duration |
| 10884521761933 | Adult-Pediatric Intubated CO2 Filter Line; Extended Duration |
| 10884521761919 | Adult-Pediatric Intubated CO2 Filter Line; Extended Duration |
| 10884521761902 | Adult-Pediatric Intubated CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521761889 | Adult-Pediatric Intubated CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521761872 | Pediatric Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency |
| 10884521761858 | Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency |
| 10884521761735 | Adult-Intermediate Bite Block Filter Line with O2 Tubing, Short-term use: Procedural/Emergency |
| 10884521761711 | Adult-Intermediate Bite Block CO2 Filter Line with O2 Connector; Short-term use: Procedural/Emer |
| 10884521761650 | Pediatric Oral-Nasal CO2 Filter Line with O2 tubing; Short-term use: Procedural/Emergency |
| 10884521761643 | Pediatric Oral-Nasal Filter Line with O2 Tubing, Short-term use: Procedural/Emergency |
| 10884521761636 | Pediatric Oral-Nasal CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521761612 | Adult Oral-Nasal CO2 Filter Line with O2 tubing; Short-term use: Procedural/Emergency |
| 10884521761575 | Adult Oral-Nasal CO2 Filter Line with O2 connector; Short-term use: Procedural/Emergency |
| 10884521761568 | Adult Oral-Nasal CO2 Filter Line with O2 connector; Short-term use: Procedural/Emergency |
| 10884521761957 | CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521777569 | Adult Oral-Nasal CO2 Filter Line with O2 connector; Short-term use: Procedural/Emergency |
| 10884521761926 | Adult-Pediatric Intubated Filter Line, Extended Duration |
| 10884521761865 | Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency |
| 10884521761841 | Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency |
| 10884521761834 | Adult Nasal Filter Line with O2 Tubing, Short-term use: Procedural/Emergency |
| 10884521761629 | Adult Oral-Nasal Filter Line with O2 tubing, Short-term use: Procedural/Emergency |
| 10884521761582 | Adult Oral-Nasal CO2 Filter Line with O2 connector, Short-term use: Procedural/Emergency |
| 10884521761605 | Adult Oral-Nasal Filter Line with O2 Tubing, Short-term use: Procedural/Emergency |
| 10884521761599 | Adult Oral-Nasal Filter Line with O2 tubing, Short-term use: Procedural/Emergency |
| 10884521761940 | Filter Line, MRI XL, Short-term use: Procedural/Emergency |
| 10884521761896 | Adult-Pediatric Intubated CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521761797 | Neonatal-Infant Nasal CO2 Filter Line; Extended Duration |
| 10884521761780 | Neonatal-Infant Nasal CO2 Filter Line; Extended Duration |
| 10884521761773 | Adult Nasal CO2 Filter Line; Extended Duration |
| 10884521761704 | Pediatric Oral-Nasal Filter Line with O2 Tubing, Extended Duration |
| 10884521761681 | Adult Oral-Nasal CO2 Filter Line with O2 Tubing, Extended Duration |
| 10884521761674 | Adult Oral-Nasal Filter Line with O2 Tubing, Extended Duration |
| 10884521761667 | Adult Oral-Nasal Filter Line with O2 Tubing, Extended Duration |
| 10884521761827 | Adult Nasal CO2 Filter Line with O2 Tubing; Extended Duration |
| 10884521761803 | Neonatal-Infant Nasal Filter Line with O2 Tubing, Extended Duration |
| 10884521761698 | Pediatric Nasal CO2 Filter Line with O2 Tubing; Extended Duration |
| 10884521771734 | Neonatal-Infant Nasal CO2 Filter Line; Short-term use: Procedural/Emergency |
| 10884521761810 | Pediatric Oral-Nasal Filter Line with O2 Tubing, Extended Duration |
| 10884521761766 | Adult-Intermediate Bite Block Filter Line with O2 Tubing, Short-term use: Procedural/Emergency |
| 10884521761759 | Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergen |
| 10884521761742 | Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergen |
| 10884521761728 | Adult-Intermediate Bite Block CO2 Filter Line with O2 Connector; Short-term use: Procedural/Emer |
| 10884521783980 | Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connect |