Qardio Forehead thermometer TD-1261

GUDID 10854894005422

QARDIO, INC.

Infrared patient thermometer, skin

• Primary Device ID: 10854894005422
• NIH Device Record Key: f6ef977e-ce52-4a02-a58b-4dcd168cbf70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qardio Forehead thermometer
• Version Model Number: TD-1261
• Catalog Number: TD-1261
• Company DUNS: 080029958
• Company Name: QARDIO, 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854894005425 [Primary]
GS1	10854894005422 [Package]; Contains: 00854894005425; Package: [64 Units]; In Commercial Distribution

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: 2021-01-18
• Device Publish Date: 2021-01-08

Devices Manufactured by QARDIO, INC.

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• 10854894005354 - QardioArm2: 2023-06-27
• 10854894005392 - Qardio Pro Cellular Blood Pressure Monitor: 2021-12-07 Pro Cellular Blood Pressure Monitor
• 10854894005415 - Qardio Pulse Oximeter: 2021-01-21
• 10854894005422 - Qardio Forehead thermometer: 2021-01-18
• 10854894005422 - Qardio Forehead thermometer: 2021-01-18
• 00854894005005 - QardioArm: 2019-11-08
• 00854894005012 - QardioArm: 2019-11-08
• 00854894005029 - QardioArm: 2019-11-08