Infrared Ear Thermometer

GUDID 00616784561233

DYNAREX CORPORATION

Infrared patient thermometer, ear Infrared patient thermometer, ear

• Primary Device ID: 00616784561233
• NIH Device Record Key: 2e1711eb-57da-4142-9e5d-de602c1be9b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrared Ear Thermometer
• Version Model Number: 5612
• 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	00616784561219 [Primary]
GS1	00616784561226 [Package]; Contains: 00616784561219; Package: [10 Units]; In Commercial Distribution
GS1	00616784561233 [Package]; Contains: 00616784561226; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041692

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

Devices Manufactured by DYNAREX CORPORATION

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• 08401173366290 - LabChoice Microscope Slides,Frosted Blue,Ground Corners: 2024-07-02 3"x 1"x1mm
• 08401173366368 - LabChoice Microscope Slides,Frosted Pink,Ground Corners: 2024-07-02 3"x1"x1mm
• 08401173366436 - LabChoice Microscope Slides,Frosted White,Ground Corner: 2024-07-02 3"x1"x1mm
• 08401173366504 - LabChoice Microscope Slides, Frosted Yellow, Ground Corner: 2024-07-02 3"x1"x1mm
• 08401173372758 - LabChoice Microscope Slides, Double Frosted, Ground Corners: 2024-07-02 3" x 1" x 1mm
• 00840117333598 - Wound Management Tray, Sterile: 2024-06-26 Contents: 1 Tray, 25 Non-woven gauze pads, 2 Cotton tip applicators, 1 Tongue depressor, 1 Bag with twist tie, 1 Towel drape.
• 00840117338012 - Debridement Kit, Sterile: 2024-06-26 Contents: 1 Cotton Tip Applicator, 1 Scalpel #11, 1 Iris Scissors, Straight, 2 Gauze Pads 4x4, 1 Adson Forceps, 1 Alcohol prep