ONE-CARE Non-Contact Infrared Thermometer 4021

GUDID 00810008218013

The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrared thermometer with two modes for multi-measurement: body mode for measuring forehead temperature and surface mode for measuring the temperature of objects such as rooms, milk, food, water, etc.

MediVena, LLC

Infrared patient thermometer, skin

• Primary Device ID: 00810008218013
• NIH Device Record Key: bca56cd6-085f-4fc9-b6e6-34a02df6a995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE Non-Contact Infrared Thermometer
• Version Model Number: 4021 ONE-CARE Non-Contact Infrared Thermometer HTD
• Catalog Number: 4021
• Company DUNS: 080740980
• Company Name: MediVena, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com

Device Dimensions

• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter
• Length: 140 Millimeter
• Width: 44 Millimeter
• Height: 37 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008218006 [Primary]
GS1	00810008218013 [Package]; Contains: 00810008218006; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203332

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: 2024-09-30
• Device Publish Date: 2024-09-20

On-Brand Devices [ONE-CARE Non-Contact Infrared Thermometer]

• 00810008218013: The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrar
• 00810008217993: The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrar