DEVICE: Diagnostix™ (00634782096748)
Device Identifier (DI) Information
Diagnostix™
5610B-38W
In Commercial Distribution
5610B-38W
AMERICAN DIAGNOSTIC CORP
5610B-38W
In Commercial Distribution
5610B-38W
AMERICAN DIAGNOSTIC CORP
Adstation Oto-Xen/Coax Oph-LED, ,9003W/Spec Disp, WB
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? |
|---|---|---|---|---|
| 16173 | Automatic-inflation electronic sphygmomanometer, non-portable |
An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.
|
Active | false |
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| ERA | Otoscope |
| HLJ | Ophthalmoscope, Battery-Powered |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
7683d9bf-7eec-4ffd-92fa-c27fcd849f1a
January 10, 2020
1
January 02, 2020
January 10, 2020
1
January 02, 2020
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-232-2670
info@adctoday.com
info@adctoday.com