Microstream Advance MVIIHH

GUDID 10884521762015

Neonatal-Infant Intubated CO2 Filter Line; High Humidity

ORIDION MEDICAL 1987 LTD.

Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use
Primary Device ID10884521762015
NIH Device Record Key011c8a34-b277-499b-967b-2ab22ab20d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrostream Advance
Version Model NumberMVIIHH
Catalog NumberMVIIHH
Company DUNS600111512
Company NameORIDION MEDICAL 1987 LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Length2 Meter
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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521762015 [Package]
Contains: 20884521762012
Package: CASE [25 Units]
In Commercial Distribution
GS120884521762012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-17
Device Publish Date2020-01-09

On-Brand Devices [Microstream Advance]

40884521520746Hook and Loop Strap
10884521771758Pediatric Nasal CO2 Filter Line; Short-term use: Procedural/Emergency
10884521771741Adult Nasal CO2 Filter Line; Short-term use: Procedural/Emergency
10884521762015Neonatal-Infant Intubated CO2 Filter Line; High Humidity
10884521762008Adult-Pediatric Intubated CO2 Filter Line; High Humidity
10884521761995Neonatal-Infant Intubated CO2 Filter Line; Extended Duration
10884521761988Neonatal-Infant Intubated CO2 Filter Line; Extended Duration
10884521761933Adult-Pediatric Intubated CO2 Filter Line; Extended Duration
10884521761919Adult-Pediatric Intubated CO2 Filter Line; Extended Duration
10884521761902Adult-Pediatric Intubated CO2 Filter Line; Short-term use: Procedural/Emergency
10884521761889Adult-Pediatric Intubated CO2 Filter Line; Short-term use: Procedural/Emergency
10884521761872Pediatric Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency
10884521761858Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency
10884521761735Adult-Intermediate Bite Block Filter Line with O2 Tubing, Short-term use: Procedural/Emergency
10884521761711Adult-Intermediate Bite Block CO2 Filter Line with O2 Connector; Short-term use: Procedural/Emer
10884521761650Pediatric Oral-Nasal CO2 Filter Line with O2 tubing; Short-term use: Procedural/Emergency
10884521761643Pediatric Oral-Nasal Filter Line with O2 Tubing, Short-term use: Procedural/Emergency
10884521761636Pediatric Oral-Nasal CO2 Filter Line; Short-term use: Procedural/Emergency
10884521761612Adult Oral-Nasal CO2 Filter Line with O2 tubing; Short-term use: Procedural/Emergency
10884521761575Adult Oral-Nasal CO2 Filter Line with O2 connector; Short-term use: Procedural/Emergency
10884521761568Adult Oral-Nasal CO2 Filter Line with O2 connector; Short-term use: Procedural/Emergency
10884521761957CO2 Filter Line; Short-term use: Procedural/Emergency
10884521777569Adult Oral-Nasal CO2 Filter Line with O2 connector; Short-term use: Procedural/Emergency
10884521761926Adult-Pediatric Intubated Filter Line, Extended Duration
10884521761865Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency
10884521761841Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency
10884521761834Adult Nasal Filter Line with O2 Tubing, Short-term use: Procedural/Emergency
10884521761629Adult Oral-Nasal Filter Line with O2 tubing, Short-term use: Procedural/Emergency
10884521761582Adult Oral-Nasal CO2 Filter Line with O2 connector, Short-term use: Procedural/Emergency
10884521761605Adult Oral-Nasal Filter Line with O2 Tubing, Short-term use: Procedural/Emergency
10884521761599Adult Oral-Nasal Filter Line with O2 tubing, Short-term use: Procedural/Emergency
10884521761940Filter Line, MRI XL, Short-term use: Procedural/Emergency
10884521761896Adult-Pediatric Intubated CO2 Filter Line; Short-term use: Procedural/Emergency
10884521761797Neonatal-Infant Nasal CO2 Filter Line; Extended Duration
10884521761780Neonatal-Infant Nasal CO2 Filter Line; Extended Duration
10884521761773Adult Nasal CO2 Filter Line; Extended Duration
10884521761704Pediatric Oral-Nasal Filter Line with O2 Tubing, Extended Duration
10884521761681Adult Oral-Nasal CO2 Filter Line with O2 Tubing, Extended Duration
10884521761674Adult Oral-Nasal Filter Line with O2 Tubing, Extended Duration
10884521761667Adult Oral-Nasal Filter Line with O2 Tubing, Extended Duration
10884521761827Adult Nasal CO2 Filter Line with O2 Tubing; Extended Duration
10884521761803Neonatal-Infant Nasal Filter Line with O2 Tubing, Extended Duration
10884521761698Pediatric Nasal CO2 Filter Line with O2 Tubing; Extended Duration
10884521771734Neonatal-Infant Nasal CO2 Filter Line; Short-term use: Procedural/Emergency
10884521761810Pediatric Oral-Nasal Filter Line with O2 Tubing, Extended Duration
10884521761766Adult-Intermediate Bite Block Filter Line with O2 Tubing, Short-term use: Procedural/Emergency
10884521761759Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergen
10884521761742Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergen
10884521761728Adult-Intermediate Bite Block CO2 Filter Line with O2 Connector; Short-term use: Procedural/Emer
10884521783980Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connect

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