Amico Diagnostic, Inc.

Basic Information

• Brand Name: Amico Diagnostic, Inc.
• Primary DI: 00697077003050
• Version / Model: TEST
• Company Name: Amico Diagnostic Incorporated
• Labeler DUNS: 203163290
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-18
• Public Version: 2
• Public Version Date: 2024-12-03
• Public Version Status: Update
• Public Device Record Key: e8eaac95-28fc-47a8-9fe6-e209166b461f
• Distribution End Date: 2024-09-18

Device Description

Diagnostic Station Ophthalmoscope & Otoscope LED, Spec Dispenser, Aneroid & Adult Cuff, Thermometer, Grey Wallboard Ophthalmoscope with AC power (DI 00697077003067) Aneroid and Blood Pressure Cuff (DI 00697077003074) Thermometer (DI 20884521008509) This is a test record to test our brand name and description fixes. This DI has not been applied to any Amico product.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	886.1570	2
ERA	Otoscope	Ear, Nose, Throat	874.4770	1
DXQ	Blood Pressure Cuff	Cardiovascular	870.1120	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14035	Intermittent electronic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.	No	Active
16156	Aneroid manual sphygmomanometer	A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.	No	Active
46786	Direct ophthalmoscope	An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00697077003050	GS1

Customer Contacts

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