Diagnostix™ 5610X-349W
GUDID 00634782087982
Adstation Oto-X/Coax Oph-X,429, 9005W/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
Ophthalmic/otologic diagnostic set| Primary Device ID | 00634782087982 |
| NIH Device Record Key | e027491d-8853-4d6b-a2a6-a6963d083588 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diagnostix™ |
| Version Model Number | 5610X-349W |
| Catalog Number | 5610X-349W |
| Company DUNS | 108999095 |
| Company Name | AMERICAN DIAGNOSTIC CORP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634782087982 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081160
FDA Product Code
| FLL | Thermometer, Electronic, Clinical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-12 |
On-Brand Devices [Diagnostix™]
| 00634782596255 | Premium Aneroid/Scope,Adult, Black, LF |
| 00634782595326 | DIAGNOSTIX Pulse Oximeter,Fingertip, Adult, Canada only |
| 00634782587994 | DIAGNOSTIX Pkt Ophthalmoscope,2.5v, LED, Burgundy |
| 00634782093747 | Adstation Oto+-X,EU |
| 00634782093730 | Adstation Oto+-X ,Throat-X, EU |
| 00634782093723 | Adstation Oto+-X ,Throat-X |
| 00634782093716 | Adstation Oto+-X ,Throat-X, EU |
| 00634782093709 | Adstation Oto+-X ,Throat-X, Clock Aner, EU |
| 00634782093693 | Adstation Oto+-X ,Throat-X, Clock Aner |
| 00634782093686 | Adstation Oto+-X ,Throat-X |
| 00634782093679 | Adstation Oto+-X ,Throat-L, EU |
| 00634782093662 | Adstation Oto+-X ,Throat-L, Clock Aner, EU |
| 00634782093655 | Adstation Oto+-X ,Throat-L, Clock Aner |
| 00634782093648 | Adstation Oto+-X ,Throat-L |
| 00634782093631 | Adstation Oto+-X ,Derm, EU |
| 00634782093624 | Adstation Oto+-X ,Derm, Clock Aner, EU |
| 00634782093617 | Adstation Oto+-X ,Derm, Clock Aner |
| 00634782093600 | Adstation Oto+-X ,Derm, Throat-X, EU |
| 00634782093594 | Adstation Oto+-X ,Derm, Throat-X |
| 00634782093587 | Adstation Oto+-X ,Derm, Throat-L, EU |
| 00634782093570 | Adstation Oto+-X ,Derm, Throat-L |
| 00634782093563 | Adstation Oto+-X ,Derm |
| 00634782093556 | Adstation Oto+-X ,Spec Disp, EU |
| 00634782093549 | Adstation Oto+-X ,Clock Aner, Spec Disp, EU |
| 00634782093532 | Adstation Oto+-X ,Clock Aner, Spec Disp |
| 00634782093525 | Adstation Oto+-X ,Throat-X, Spec Disp, WB |
| 00634782093518 | Adstation Oto+-X ,Throat-X, Spec Disp, EU, WB |
| 00634782093501 | Adstation Oto+-X ,Throat-X, Spec Disp, EU |
| 00634782093495 | Adstation Oto+-X ,Throat-X, 9005W/Spec Disp, WB |
| 00634782093488 | Adstation Oto+-X/Throat-X,9005W/Spec Disp, WB, EU |
| 00634782093471 | Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, WB |
| 00634782093464 | Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU, WB |
| 00634782093457 | Adstation Oto+-X/Throat-X,Clock Aner/Spec Disp, EU |
| 00634782093440 | Adstation Oto+-X ,Throat-X, Clock Aner/Spec Disp |
| 00634782093433 | Adstation Oto+-X ,Throat-X, Spec Disp |
| 00634782093426 | Adstation Oto+-X ,Throat-L, Spec Disp, WB |
| 00634782093419 | Adstation Oto+-X ,Throat-L, Spec Disp, EU, WB |
| 00634782093402 | Adstation Oto+-X ,Throat-L, Spec Disp, EU |
| 00634782093396 | Adstation Oto+-X ,Throat-L, 9005W/Spec Disp, WB |
| 00634782093389 | Adstation Oto+-X/Throat-L,9005W/Spec Disp, EU, WB |
| 00634782093372 | Adstation Oto+-X/Throat-L,Clock Aner/Spec Disp, WB |
| 00634782093365 | Adstation Oto+-X/Throat-L,ClockAner/Spec Disp, EU, WB |
| 00634782093358 | Adstation Oto+-X/Throat-L,Clock Aner/Spec Disp, EU |
| 00634782093341 | Adstation Oto+-X ,Throat-L, Clock Aner/Spec Disp |
| 00634782093334 | Adstation Oto+-X ,Throat-L, Spec Disp |
| 00634782093327 | Adstation Oto+-X ,Derm, Spec Disp, WB |
| 00634782093310 | Adstation Oto+-X ,Derm, Spec Disp, EU, WB |
| 00634782093303 | Adstation Oto+-X ,Derm, Spec Disp, EU |
| 00634782093297 | Adstation Oto+-X ,Derm, 9005W/Spec Disp, WB |
| 00634782093280 | Adstation Oto+-X ,Derm, 9005W/Spec Disp, EU, WB |
Trademark Results [Diagnostix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIAGNOSTIX 78149521 not registered Dead/Abandoned |
Pilatus Aircraft, Ltd. 2002-07-31 |
 DIAGNOSTIX 76257729 not registered Dead/Abandoned |
4 Kids Entertainment, Inc. 2001-05-14 |
 DIAGNOSTIX 75454154 not registered Dead/Abandoned |
Intramedica, Corp. 1998-03-20 |
 DIAGNOSTIX 75022586 not registered Dead/Abandoned |
Diagnostix, Inc. 1995-11-20 |
 DIAGNOSTIX 75022585 not registered Dead/Abandoned |
Diagnostix, Inc. 1995-11-20 |
 DIAGNOSTIX 74417786 not registered Dead/Abandoned |
SERVICESOFT CORPORATION 1993-07-28 |
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