Diagnostix™ 54380A

GUDID 00634782602093

Diagnostix Portable Set, 3.5v USB, PMV OtoL/Coax Oph X,

AMERICAN DIAGNOSTIC CORP

Ophthalmic/otologic diagnostic set

• Primary Device ID: 00634782602093
• NIH Device Record Key: e6681163-1f00-4ec9-8c0c-055d0e25a204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostix™
• Version Model Number: 54380A
• Catalog Number: 54380A
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782100582 [Primary]
GS1	00634782602093 [Package]; Contains: 00634782100582; Package: Master Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932506

FDA Product Code

• ERA: Otoscope

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: 2024-01-04
• Device Publish Date: 2023-12-27

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• 00634782093747: Adstation Oto+-X,EU
• 00634782093730: Adstation Oto+-X ,Throat-X, EU
• 00634782093723: Adstation Oto+-X ,Throat-X
• 00634782093716: Adstation Oto+-X ,Throat-X, EU
• 00634782093709: Adstation Oto+-X ,Throat-X, Clock Aner, EU
• 00634782093693: Adstation Oto+-X ,Throat-X, Clock Aner
• 00634782093686: Adstation Oto+-X ,Throat-X
• 00634782093679: Adstation Oto+-X ,Throat-L, EU
• 00634782093662: Adstation Oto+-X ,Throat-L, Clock Aner, EU
• 00634782093655: Adstation Oto+-X ,Throat-L, Clock Aner
• 00634782093648: Adstation Oto+-X ,Throat-L
• 00634782093631: Adstation Oto+-X ,Derm, EU
• 00634782093624: Adstation Oto+-X ,Derm, Clock Aner, EU
• 00634782093617: Adstation Oto+-X ,Derm, Clock Aner
• 00634782093600: Adstation Oto+-X ,Derm, Throat-X, EU
• 00634782093594: Adstation Oto+-X ,Derm, Throat-X
• 00634782093587: Adstation Oto+-X ,Derm, Throat-L, EU
• 00634782093570: Adstation Oto+-X ,Derm, Throat-L
• 00634782093563: Adstation Oto+-X ,Derm
• 00634782093556: Adstation Oto+-X ,Spec Disp, EU
• 00634782093549: Adstation Oto+-X ,Clock Aner, Spec Disp, EU
• 00634782093532: Adstation Oto+-X ,Clock Aner, Spec Disp
• 00634782093525: Adstation Oto+-X ,Throat-X, Spec Disp, WB
• 00634782093518: Adstation Oto+-X ,Throat-X, Spec Disp, EU, WB
• 00634782093501: Adstation Oto+-X ,Throat-X, Spec Disp, EU
• 00634782093495: Adstation Oto+-X ,Throat-X, 9005W/Spec Disp, WB
• 00634782093488: Adstation Oto+-X/Throat-X,9005W/Spec Disp, WB, EU
• 00634782093471: Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, WB
• 00634782093464: Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU, WB
• 00634782093457: Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU
• 00634782093440: Adstation Oto+-X ,Throat-X, Clock Aner/Spec Disp
• 00634782093433: Adstation Oto+-X ,Throat-X, Spec Disp
• 00634782093426: Adstation Oto+-X ,Throat-L, Spec Disp, WB
• 00634782093419: Adstation Oto+-X ,Throat-L, Spec Disp, EU, WB
• 00634782093402: Adstation Oto+-X ,Throat-L, Spec Disp, EU
• 00634782093396: Adstation Oto+-X ,Throat-L, 9005W/Spec Disp, WB
• 00634782093389: Adstation Oto+-X/Throat-L,9005W/Spec Disp, EU, WB
• 00634782093372: Adstation Oto+-X/Throat-L,Clock Aner/Spec Disp, WB
• 00634782093365: Adstation Oto+-X/Throat-L,ClockAner/Spec Disp, EU, WB
• 00634782093358: Adstation Oto+-X/Throat-L,Clock Aner/Spec Disp, EU
• 00634782093341: Adstation Oto+-X ,Throat-L, Clock Aner/Spec Disp
• 00634782093334: Adstation Oto+-X ,Throat-L, Spec Disp
• 00634782093327: Adstation Oto+-X ,Derm, Spec Disp, WB
• 00634782093310: Adstation Oto+-X ,Derm, Spec Disp, EU, WB
• 00634782093303: Adstation Oto+-X ,Derm, Spec Disp, EU
• 00634782093297: Adstation Oto+-X ,Derm, 9005W/Spec Disp, WB
• 00634782093280: Adstation Oto+-X ,Derm, 9005W/Spec Disp, EU, WB