ISA™ Gas Exhaust Kit

GUDID 07350046132139

Masimo Sweden AB

Anaesthesia workstation gas scavenger
Primary Device ID07350046132139
NIH Device Record Key2c14d097-246a-4b0d-9719-a09ca6ac8338
Commercial Distribution StatusIn Commercial Distribution
Brand NameISA™ Gas Exhaust Kit
Version Model Number4409
Company DUNS632369067
Company NameMasimo Sweden AB
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350046132139 [Unit of Use]
GS117350046132136 [Primary]

FDA Product Code

BZAConnector, Airway (Extension)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-22
Device Publish Date2021-09-14

Devices Manufactured by Masimo Sweden AB

07350046132139 - ISA™ Gas Exhaust Kit2021-09-22
07350046132139 - ISA™ Gas Exhaust Kit2021-09-22
07350046132658 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula2021-01-26
07350046132665 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula2021-01-26
07350046132672 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula with O22021-01-26
07350046132689 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula with O22021-01-26
07350046132290 - ISA™ CO22021-01-18
07350046131996 - Radius PCG™2020-10-27
07350046132009 - Radius PCG™2020-10-27

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