Infrared Forehead Thermometer

GUDID 00616784561332

DYNAREX CORPORATION

Infrared patient thermometer, skin

• Primary Device ID: 00616784561332
• NIH Device Record Key: 4680e76a-5ba7-4ca6-aac4-bc8ad7d0f31c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrared Forehead Thermometer
• Version Model Number: 5613
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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	00616784561325 [Primary]
GS1	00616784561332 [Package]; Contains: 00616784561325; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

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: 2016-09-24

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