TotalExam® Oto 2.0 GMD5505HD22

GUDID 00850033167030

TotalExam® Oto 2.0, Otoscope Camera

GLOBALMEDIA GROUP, LLC

Multi-purpose digital medical camera

• Primary Device ID: 00850033167030
• NIH Device Record Key: d9ac6b47-cdf6-4ef6-8cc0-37d9b22f5767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TotalExam® Oto 2.0
• Version Model Number: GMD5505HD22
• Catalog Number: GMD5505HD22
• Company DUNS: 103201849
• Company Name: GLOBALMEDIA GROUP, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033167030 [Primary]

FDA Product Code

• KZF: Device, Medical Examination, Ac Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

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• 00850033167160 - Total Vitals: 2023-12-18 The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive
• 00850033167177 - Total ECG: 2023-12-18 ECG device incorporating a wireless 12-Lead ECG system, Windows®-based CardioVu software using the Glasgow 12-lead ECG analysis