Physiologic Accuflex Pro+ Digital Thermometer

GUDID 00057565976585

The Accuflex Pro+ Digital Thermometer provides a quick and accurate reading of an individual’s body temperature. It features a comfortable and flexible tip along with beeper and memory functions. It is intended to measure body temperature orally, rectally, or under the arm. Perfect for clinical or home use for people of all ages.

A.M.G. Médicale Inc

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 00057565976585
• NIH Device Record Key: eb2f4ab5-dcba-4088-a414-5e6f4ccc5db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Physiologic Accuflex Pro+ Digital Thermometer
• Version Model Number: 016-658
• Company DUNS: 207372814
• Company Name: A.M.G. Médicale 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00057565166580 [Primary]
GS1	00057565976585 [Package]; Contains: 00057565166580; Package: Box [6 Units]; In Commercial Distribution
GS1	00057565976592 [Package]; Package: Master Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183393

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: 2021-08-09
• Device Publish Date: 2021-08-01

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