AccessGUDID - DEVICE: Amico Diagnostic Wallboard (00697077001575)

GUDID

Device Identifier (DI) Information

Brand Name: Amico Diagnostic Wallboard
Version or Model: DS-ULG-CLFL-DXI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Amico Diagnostic Incorporated

Primary DI Number: 00697077001575
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203163290 *Terms of Use

Device Description: Diag. Station -Oph & Oto, LED, Spec Disp, IR Therm, Grey Wall brd Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) Genius 3 Tympanic Thermometer and Base (DI 10884521738522)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17887	Infrared patient thermometer, ear	A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLI	Ophthalmoscope, Ac-Powered
ERA	Otoscope
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8568de71-f0d4-4a9f-a42f-0ef0b74e31f6
Public Version Date: December 03, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016