ISA™ AX+

GUDID 07350046131866

Masimo Sweden AB

Patient monitoring system module, multiple-gas
Primary Device ID07350046131866
NIH Device Record Keyecb584ea-b55d-4484-820b-ff4dd8d67a37
Commercial Distribution StatusIn Commercial Distribution
Brand NameISA™ AX+
Version Model NumberAX+ LEMO
Company DUNS632369067
Company NameMasimo Sweden AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350046131866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-03
Device Publish Date2016-08-11

On-Brand Devices [ISA™ AX+ ]

07350046131866AX+ LEMO
07350046131859AX+ ROOT
07350046131842AX+

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