Adstation™ 5442L

GUDID 00634782076764

Coax Plus Ophthalmoscope Head,,LED

AMERICAN DIAGNOSTIC CORP

Ophthalmic/otologic diagnostic set

• Primary Device ID: 00634782076764
• NIH Device Record Key: 44b1f3d9-0703-404a-8b86-af29d0143aae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adstation™
• Version Model Number: 5442L
• Catalog Number: 5442L
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782076764 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Adstation™ ]

• 00634782087661: ADSTATION Wallboard,Large, w/hardware
• 00634782085667: Adstation Otoscope,LED, w/Spec/ThroatX/750W/Wall
• 00634782085650: Adstation Otoscope,LED, w/Spec/ThroatX/Wall
• 00634782084264: Diagnostix Portable Set, 3.5v,OtoX/Oph2X, Soft, Euro
• 00634782084257: Diagnostix Portable Set, 3.5v,OtoX/Oph2X, Soft
• 00634782084240: Diagnostix Portable Set, 3.5v,OtoL/Oph2L, Soft, Euro
• 00634782084233: Diagnostix Portable Set, 3.5v,OtoL/Oph2L, Soft
• 00634782084226: Diagnostix Portable Set, 3.5v,OtoX/Oph2L, Soft, Euro
• 00634782084219: Diagnostix Portable Set, 3.5v,OtoX/Oph2L, Soft
• 00634782084202: Diagnostix Portable Set, 3.5v,OtoL/Oph2X, Soft, Euro
• 00634782084196: Diagnostix Portable Set, 3.5v,OtoL/Oph2X, Soft
• 00634782084189: Diagnostix Portable Set, 3.5v,OtoX/OphX, Soft, Euro
• 00634782084172: Diagnostix Portable Set, 3.5v,OtoX/OphX, Soft
• 00634782084165: Diagnostix Portable Set, 3.5v,OtoL/OphL, Soft, Euro
• 00634782084158: Diagnostix Portable Set, 3.5v,OtoL/OphL, Soft
• 00634782084141: Diagnostix Portable Set, 3.5v,OtoX/OphL, Soft, Euro
• 00634782084134: Diagnostix Portable Set, 3.5v,OtoX/OphL, Soft
• 00634782084127: Diagnostix Portable Set, 3.5v,OtoL/OphX, Soft, Euro
• 00634782084110: Diagnostix Portable Set, 3.5v,OtoL/OphX, Soft
• 00634782884949: WA Specula Adapter,3.5v Diagnostix
• 00634782083403: Adstation Otoscope,LED, w/Spec/ThroatL/750W/Wall
• 00634782083397: Adstation Otoscope,LED, w/Spec/ThroatL/Wall
• 00634782083380: Adstation Otoscope,LED, w/Spec/Derm/750W/Wall
• 00634782083373: Adstation Otoscope,LED, w/Spec/Derm/Wall
• 00634782584634: Ophthalmoscope Head-5112NL,LED
• 00634782584627: Otoscope Head-5111NL,LED
• 00634782584603: Diagnostix Pckt Ophthalmoscope,Soft case, LED
• 00634782584597: Diagnostix Pckt Ophthalmoscope,Hard case, LED
• 00634782584580: Diagnostix Pocket Otoscope,Soft case, LED
• 00634782584573: Diagnostix Pocket Otoscope,Hard case, LED
• 00634782584566: Diagnostix Pocket Oto/Oph Set,Soft case, LED
• 00634782584559: Diagnostix Pocket Oto/Oph Set,Hard case, LED
• 00634782082758: Diagnostix Throat Illuminator,3.5v, LED, Euro
• 00634782082741: Diagnostix Throat Illuminator,3.5v, Xenon, Euro
• 00634782082734: Diagnostix Throat Illuminator,3.5v, LED
• 00634782082727: Diagnostix Throat Illuminator,3.5v, Xenon
• 00634782082710: Transformer w/Handle,Euro, 230V
• 00634782082703: Transformer w/Extension module,Euro, 230V
• 00634782082697: Transformer w/Extension module,USA, 120v
• 00634782082680: Transformer w/Handle,USA, 120v
• 00634782082673: Wall Extension w/Handle,
• 00634782082666: Adstation Throat Illuminator,Xen, Euro
• 00634782082659: Adstation Throat Illuminator,Xen, w/750W, Euro
• 00634782082642: Adstation Throat Illuminator,Xen, w/750W
• 00634782082635: Throat Illuminator Head, 3.5v,Xenon
• 00634782082628: Adstation Throat Illuminator,Xen
• 00634782082611: Adstation Throat Illuminator,LED, Euro
• 00634782082604: Adstation Throat Illuminator,LED, w/750W, Euro
• 00634782082598: Adstation Throat Illuminator,LED, w/750W
• 00634782082581: Throat Illuminator Head, 3.5v,LED