LoFlo Sidestream Consumables

GUDID 00847946024079

KIT, ADAPTER, AIRWAY, PEDIATRIC/INFANT, BOX OF 10, (REF: 3572INF-00)

Zoll Medical Corporation

Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use Gas dehumidification tubing set, single-use
Primary Device ID00847946024079
NIH Device Record Key2e9b0bb2-9afd-40ba-bc56-ee016d8d2178
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoFlo Sidestream Consumables
Version Model Number9355-0310
Company DUNS055363428
Company NameZoll Medical Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 0
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946024079 [Primary]

FDA Product Code

MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-25
Device Publish Date2021-06-17

On-Brand Devices [LoFlo Sidestream Consumables]

00847946024086KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, PEDIATRIC/INFANT, BOX OF 10, (REF: 3573INF-00)
00847946024079KIT, ADAPTER, AIRWAY, PEDIATRIC/INFANT, BOX OF 10, (REF: 3572INF-00)
00847946024017KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, ADULT/PEDIATRIC, BOX OF 10, (REF: 3573ADU-00)
00847946024000KIT, ADAPTER, AIRWAY, ADULT/PEDIATRIC, BOX OF 10, (REF: 3572ADU-00)
00847946023997CANNULA, ORAL/NASAL, PEDIATRIC, CO2, W/O2, BOX OF 10, (REF: 3571PED-00)
00847946023980CANNULA, ORAL/NASAL, ADULT, CO2, W/O2, BOX OF 10, (REF: 3571ADU-00)
00847946023973CANNULA, NASAL, PEDIATRIC, CO2/WO2, BOX OF 10, (REF: 3569PED-00)
00847946023966CANNULA, NASAL, ADULT, CO2, W/O2, BOX OF 10, (REF: 3569ADU-00)
00847946023959CANNULA, ORAL/NASAL, PEDIATRIC, CO2 SAMPLING, BOX OF 10, (REF: 3570PED-00)
00847946023942CANNULA, ORAL/NASAL, ADULT, CO2 SAMPLING, BOX OF 10, (REF: 3570ADU-00)
00847946023935CANNULA, NASAL, INFANT, CO2 SAMPLING, BOX OF 10, (REF: 3568INF-00)
00847946023928CANNULA, NASAL, PEDIATRIC, CO2 SAMPLING, BOX OF 10, (REF: 3568PED-00)
00847946023911CANNULA, NASAL, ADULT, CO2 SAMPLING, BOX OF 10, (REF: 3568ADU-00)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.