CMI Health

GUDID 00850000967052

PC-66L Handheld Pulse Oximeter with Infant Foot Wrap Sensor

CMI HEALTH INC.

Pulse oximeter

• Primary Device ID: 00850000967052
• NIH Device Record Key: 9f0f3c34-6c04-42f2-9a04-360831b85387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMI Health
• Version Model Number: PC-66L W72
• Company DUNS: 079963616
• Company Name: CMI HEALTH INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000967052 [Primary]

FDA Product Code

• PGJ: Oximeter, Wellness

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: 2025-05-01
• Device Publish Date: 2025-04-23

On-Brand Devices [CMI Health]

• 00850000967007: CMI Health PC-900B Handheld Capnograph and Oximeter
• 00850000967052: PC-66L Handheld Pulse Oximeter with Infant Foot Wrap Sensor
• 00850000967038: PC-66L Handheld Pulse Oximeter
• 00850000967014: PC-66L Pulse Oximeter with Adult Continuous Sensor