Diagnostix™ 54380A

GUDID 00634782602093

Diagnostix Portable Set, 3.5v USB, PMV OtoL/Coax Oph X,

AMERICAN DIAGNOSTIC CORP

Ophthalmic/otologic diagnostic set
Primary Device ID00634782602093
NIH Device Record Keye6681163-1f00-4ec9-8c0c-055d0e25a204
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiagnostix™
Version Model Number54380A
Catalog Number54380A
Company DUNS108999095
Company NameAMERICAN DIAGNOSTIC CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100634782100582 [Primary]
GS100634782602093 [Package]
Contains: 00634782100582
Package: Master Case [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERAOtoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-04
Device Publish Date2023-12-27

On-Brand Devices [Diagnostix™]

00634782596255Premium Aneroid/Scope,Adult, Black, LF
00634782595326DIAGNOSTIX Pulse Oximeter,Fingertip, Adult, Canada only
00634782587994DIAGNOSTIX Pkt Ophthalmoscope,2.5v, LED, Burgundy
00634782093747Adstation Oto+-X,EU
00634782093730Adstation Oto+-X ,Throat-X, EU
00634782093723Adstation Oto+-X ,Throat-X
00634782093716Adstation Oto+-X ,Throat-X, EU
00634782093709Adstation Oto+-X ,Throat-X, Clock Aner, EU
00634782093693Adstation Oto+-X ,Throat-X, Clock Aner
00634782093686Adstation Oto+-X ,Throat-X
00634782093679Adstation Oto+-X ,Throat-L, EU
00634782093662Adstation Oto+-X ,Throat-L, Clock Aner, EU
00634782093655Adstation Oto+-X ,Throat-L, Clock Aner
00634782093648Adstation Oto+-X ,Throat-L
00634782093631Adstation Oto+-X ,Derm, EU
00634782093624Adstation Oto+-X ,Derm, Clock Aner, EU
00634782093617Adstation Oto+-X ,Derm, Clock Aner
00634782093600Adstation Oto+-X ,Derm, Throat-X, EU
00634782093594Adstation Oto+-X ,Derm, Throat-X
00634782093587Adstation Oto+-X ,Derm, Throat-L, EU
00634782093570Adstation Oto+-X ,Derm, Throat-L
00634782093563Adstation Oto+-X ,Derm
00634782093556Adstation Oto+-X ,Spec Disp, EU
00634782093549Adstation Oto+-X ,Clock Aner, Spec Disp, EU
00634782093532Adstation Oto+-X ,Clock Aner, Spec Disp
00634782093525Adstation Oto+-X ,Throat-X, Spec Disp, WB
00634782093518Adstation Oto+-X ,Throat-X, Spec Disp, EU, WB
00634782093501Adstation Oto+-X ,Throat-X, Spec Disp, EU
00634782093495Adstation Oto+-X ,Throat-X, 9005W/Spec Disp, WB
00634782093488Adstation Oto+-X/Throat-X,9005W/Spec Disp, WB, EU
00634782093471Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, WB
00634782093464Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU, WB
00634782093457Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU
00634782093440Adstation Oto+-X ,Throat-X, Clock Aner/Spec Disp
00634782093433Adstation Oto+-X ,Throat-X, Spec Disp
00634782093426Adstation Oto+-X ,Throat-L, Spec Disp, WB
00634782093419Adstation Oto+-X ,Throat-L, Spec Disp, EU, WB
00634782093402Adstation Oto+-X ,Throat-L, Spec Disp, EU
00634782093396Adstation Oto+-X ,Throat-L, 9005W/Spec Disp, WB
00634782093389Adstation Oto+-X/Throat-L,9005W/Spec Disp, EU, WB
00634782093372Adstation Oto+-X/Throat-L,Clock Aner/Spec Disp, WB
00634782093365Adstation Oto+-X/Throat-L,ClockAner/Spec Disp, EU, WB
00634782093358Adstation Oto+-X/Throat-L,Clock Aner/Spec Disp, EU
00634782093341Adstation Oto+-X ,Throat-L, Clock Aner/Spec Disp
00634782093334Adstation Oto+-X ,Throat-L, Spec Disp
00634782093327Adstation Oto+-X ,Derm, Spec Disp, WB
00634782093310Adstation Oto+-X ,Derm, Spec Disp, EU, WB
00634782093303Adstation Oto+-X ,Derm, Spec Disp, EU
00634782093297Adstation Oto+-X ,Derm, 9005W/Spec Disp, WB
00634782093280Adstation Oto+-X ,Derm, 9005W/Spec Disp, EU, WB

Trademark Results [Diagnostix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIAGNOSTIX
DIAGNOSTIX
78149521 not registered Dead/Abandoned
Pilatus Aircraft, Ltd.
2002-07-31
DIAGNOSTIX
DIAGNOSTIX
76257729 not registered Dead/Abandoned
4 Kids Entertainment, Inc.
2001-05-14
DIAGNOSTIX
DIAGNOSTIX
75454154 not registered Dead/Abandoned
Intramedica, Corp.
1998-03-20
DIAGNOSTIX
DIAGNOSTIX
75022586 not registered Dead/Abandoned
Diagnostix, Inc.
1995-11-20
DIAGNOSTIX
DIAGNOSTIX
75022585 not registered Dead/Abandoned
Diagnostix, Inc.
1995-11-20
DIAGNOSTIX
DIAGNOSTIX
74417786 not registered Dead/Abandoned
SERVICESOFT CORPORATION
1993-07-28

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