DEVICE: Amico Diagnostic Wallboard (00697077001483)
Device Identifier (DI) Information
Amico Diagnostic Wallboard
DS-ULG-CHFH-DAI
In Commercial Distribution
Amico Diagnostic Incorporated
DS-ULG-CHFH-DAI
In Commercial Distribution
Amico Diagnostic Incorporated
Diag. Station -Oph & Oto, Spec Disp, Aneroid & Adlt Cuff, IR Therm, Grey Wallbrd
Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769)
Diagnostic Station Wall Mount, Ophthal & Oto Halogen (DI 00697077001285)
Genius 3 Tympanic Thermometer and Base (DI 10884521738522)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
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.
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HLI | Ophthalmoscope, Ac-Powered |
ERA | Otoscope |
DXQ | Blood Pressure Cuff |
FLL | Thermometer, Electronic, Clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
53219e9b-320c-4b97-87b9-9736d27e4334
December 03, 2024
4
September 24, 2016
December 03, 2024
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined