LinkTemp LMP001

GUDID 00851028001391

Non-Contact Infrared Thermometer

LINKS MEDICAL PRODUCTS INC

Intermittent electronic patient thermometer

• Primary Device ID: 00851028001391
• NIH Device Record Key: b5d7a5a3-38f8-44d9-aaaa-53a82b4759aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LinkTemp
• Version Model Number: LMP001
• Catalog Number: LMP001
• Company DUNS: 839081445
• Company Name: LINKS MEDICAL PRODUCTS 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: false
• 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

Customer Support Contacts

• Phone: 949-753-0001
• Email: scampbell@linksmed.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851028001391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130231

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-24

Devices Manufactured by LINKS MEDICAL PRODUCTS INC

• 00851028001094 - LMP Manuka Fill: 2024-01-22 Wound dressing consisting of 100% Manuka Honey in a 1.5 oz tube.
• 10851028001107 - LMP Manuka Fill: 2024-01-22 Wound dressing consisting of 100% Manuka Honey in a 0.5 oz tube.
• 10851028001169 - LMP Manuka IG: 2024-01-22 Honey-impregnated gauze wound dressing
• 10851028001350 - LMP Manuka IG Max: 2024-01-22 Honey-impregnated gauze wound dressing
• 10851028001374 - LMP Manuka IG Max Rope: 2024-01-22 Honey-impregnated gauze wound dressing
• 10851028001404 - LMP Manuka Foam Air: 2024-01-22 Honey-impregnated foam wound dressing
• 00851028001391 - LinkTemp: 2018-07-06Non-Contact Infrared Thermometer
• 00851028001391 - LinkTemp: 2018-07-06 Non-Contact Infrared Thermometer