Radius PCG™ 655100

GUDID 07350046131996

Masimo Sweden AB

Patient monitoring system module, carbon dioxide

• Primary Device ID: 07350046131996
• NIH Device Record Key: a654be36-c3a7-415f-beb8-24ce190eda2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radius PCG™
• Version Model Number: EMMA Bluetooth kPa
• Catalog Number: 655100
• 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: true
• 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	07350046131996 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-27
• Device Publish Date: 2020-10-19

On-Brand Devices [Radius PCG™]

• 07350046132009: EMMA Bluetooth mmHg
• 07350046131996: EMMA Bluetooth kPa