rainbow SET 4183

GUDID 00843997010825

rainbow SET CARESCAPE SpO2 - Masimo Pulse CO-Oximetry

MASIMO CORPORATION

Patient monitoring system module, pulse oximetry

• Primary Device ID: 00843997010825
• NIH Device Record Key: ee461e48-9e8f-4da7-87f8-59fffa183be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rainbow SET
• Version Model Number: 4183
• Catalog Number: 4183
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997010825 [Primary]

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-03
• Device Publish Date: 2023-02-13

On-Brand Devices [rainbow SET]

• 10843997012741: rainbow SET module
• 10843997012604: rainbow SET module
• 00843997011648: 4100
• 00843997013918: rainbow SET Module
• 00843997010818: rainbow SET CARESCAPE SpO2 - Masimo Pulse CO-Oximetry
• 00843997010825: rainbow SET CARESCAPE SpO2 - Masimo Pulse CO-Oximetry