DEVICE: Diagnostix™ (00634782092023)

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Device Record History
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Device Identifier (DI) Information
Diagnostix™
5680X-36LEU
In Commercial Distribution
5680X-36LEU
AMERICAN DIAGNOSTIC CORP
00634782092023
GS1

1
108999095 *Terms of Use
Adstation Oto+-X/Coax Oph-X,Throat-L/Spec Disp, EU
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45084 Ophthalmic/otologic diagnostic set
A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HLJ Ophthalmoscope, Battery-Powered
ERA Otoscope
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K950914 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
808d3ec0-3048-473a-8e23-956edebb823d
July 06, 2018
3
February 09, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-800-232-2670
info@adctoday.com
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