LIFEE

GUDID 00850067829034

Caf Medical Solutions, Inc

Electrocardiograph, professional, multichannel

• Primary Device ID: 00850067829034
• NIH Device Record Key: 1b313256-4e91-4547-ae37-98db950bb565
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFEE
• Version Model Number: LE-12CH
• Company DUNS: 043862669
• Company Name: Caf Medical Solutions, 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850067829034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220362

FDA Product Code

• DPS: Electrocardiograph

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: 2025-02-20
• Device Publish Date: 2025-02-12

On-Brand Devices [LIFEE]

• 00850067829072: LM-15
• 00850067829065: LM-12
• 00850067829058: LM-10
• 00850067829041: LM-8
• 00850067829034: LE-12CH
• 00850067829027: LMPLUS-17
• 00850067829010: LMPLUS-15
• 00850067829003: LMPLUS-12