ISA™ AX+

GUDID 07350046131859

Masimo Sweden AB

Patient monitoring system module, multiple-gas

• Primary Device ID: 07350046131859
• NIH Device Record Key: b61aaebf-8ab3-4ec6-a527-0df3314d4bb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISA™ AX+
• Version Model Number: AX+ ROOT
• Company DUNS: 632369067
• Company Name: Masimo Sweden AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350046131859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103604

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
• NHQ: Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-03
• Device Publish Date: 2016-08-11

On-Brand Devices [ISA™ AX+]

• 07350046131866: AX+ LEMO
• 07350046131859: AX+ ROOT
• 07350046131842: AX+