SAFE-MATE

GUDID 00846127199377

CASE-MATE, INC.

Infrared patient thermometer, skin

• Primary Device ID: 00846127199377
• NIH Device Record Key: ab4ff034-2fe9-4744-a617-fa99a459de14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFE-MATE
• Version Model Number: LX-26E WHITE
• Company DUNS: 790486612
• Company Name: CASE-MATE, 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: 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	00846127199377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160816

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-07-30
• Device Publish Date: 2020-07-22