OxyKnight

GUDID 00850000967410

OxyKnight Fingertip Oximeter CF-100A

CMI HEALTH INC.

Pulse oximeter

• Primary Device ID: 00850000967410
• NIH Device Record Key: 520a5fd6-e2b4-42c6-8c87-211ed52b79f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyKnight
• Version Model Number: CF-100A
• Company DUNS: 079963616
• Company Name: CMI HEALTH INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000967410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211632

FDA Product Code

• DQA: Oximeter

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: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [OxyKnight]

• 00850000967410: OxyKnight Fingertip Oximeter CF-100A
• 00850000967403: OxyKnight Fingertip Oximeter CF-100B
• 00850000967304: OxyKnight Fingertip Oximeter CF-100