Diagnostix™

Basic Information

• Brand Name: Diagnostix™
• Primary DI: 00634782100551
• Version / Model: 54313
• Catalog Number: 54313
• Company Name: AMERICAN DIAGNOSTIC CORP
• Labeler DUNS: 108999095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-27
• Public Version: 1
• Public Version Date: 2024-01-04
• Public Version Status: New
• Public Device Record Key: 9b7a0fbb-90fa-40aa-a89d-ce679186c909

Device Description

Diagnostix Portable 3.5v USB, Dermascope, LED,

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00634782602062	GS1	Master Case	10	In Commercial Distribution
Primary	00634782100551	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Finger Thickness .31 to .79 inches.

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity