DEVICE: Amico Diagnostic Wallboard (00697077002282)

Device Identifier (DI) Information

Amico Diagnostic Wallboard
DS-ULG-CHFL-DAO
In Commercial Distribution

Amico Diagnostic Incorporated
00697077002282
GS1

1
203163290 *Terms of Use
Diag Station, Oph Hal & Oto LED, Spec Disp, Aneroid & Adlt Cuff, Therm, Wall brd Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal Halogen & Oto LED (DI 00697077001308) 3000 AD Electronic Thermometer (DI 20884521008509)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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?
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.
Active false
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.
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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
DXQ Blood Pressure Cuff
ERA Otoscope
HLI Ophthalmoscope, Ac-Powered
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

7ad97994-99e6-4c77-af8b-3c2d0264a828
February 14, 2025
4
September 20, 2017
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
1-877-264-2697
info@amico-accessories.com
CLOSE