ISA™ OR+

GUDID 07350046131835

Masimo Sweden AB

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• Primary Device ID: 07350046131835
• NIH Device Record Key: 6e317bd9-3bc2-4d1a-a0fc-d8c211bb8432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISA™ OR+
• Version Model Number: OR+ LEMO
• 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	07350046131835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103604

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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™ OR+]

• 07350046131835: OR+ LEMO
• 07350046131828: OR+ ROOT
• 07350046131811: OR+