Infrared Ear Thermometer

GUDID 00616784561233

DYNAREX CORPORATION

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

• 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3": 2024-11-19
• 00840117341210 - Medicine Cups 1oz: 2024-11-05
• 00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm: 2024-11-01 Sterile-EO
• 00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm: 2024-11-01 Sterile-EO
• 00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm: 2024-11-01 Sterile-EO
• 00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm: 2024-11-01 Sterile-Eo
• 00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm: 2024-11-01 Sterile-Eo
• 00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm: 2024-11-01 Sterile-Eo