Elate-Tech

GUDID 00810477028052

AMPLIM, LLC

Infrared patient thermometer, skin

• Primary Device ID: 00810477028052
• NIH Device Record Key: 589a94ce-2df6-4360-9b95-dfe01b45a2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elate-Tech
• Version Model Number: AL1
• Company DUNS: 080521945
• Company Name: AMPLIM, LLC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810477028052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180207
• Premarket Notification: K210565

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: 2022-08-05
• Device Publish Date: 2022-07-28

On-Brand Devices [Elate-Tech]

• 00810477028083: AL2
• 00810477028052: AL1