FDA.reportPublic FDA data

Diagnostix™

Primary DI
00634782089214
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
56802B-57
Catalog number
56802B-57
Device description
Adstation Oto+-X/Coax+Oph-L,Derm/Clock Aner
Published
2018-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff
ERAOtoscope
HLJOphthalmoscope, Battery-Powered
IBJLight, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2
ERAOtoscopeEar, Nose, Throat1
HLJOphthalmoscope, Battery-PoweredOphthalmic2
IBJLight, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782089214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782089214006347820892146347820892140634782089214

GMDN Terms#

Term, Definition table
TermDefinition
Aneroid manual sphygmomanometerA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782102524Diagnostix™805MTA805MTA2026-10-16
00634782102449Multikuf™731-MCC1UB731-MCC1UB2026-10-06
00634782101725Diagnostix™805M805M2026-03-30
00634782102357ADView® 2.69006BPC9006BPC2026-10-06
00634782102456Diagnostix™54310LUB54310LUB2026-10-06
00634782102517ADC8974MAD8974MAD2026-10-06
00634782096427Multikuf™731-MCC1731-MCC12020-08-29
00634782102159Diagnostix™805NWWA805NWWA2026-08-26
00634782102166Diagnostix™805NMWA805NMWA2026-08-26
00634782102173Diagnostix™805NDWA805NDWA2026-08-26
00634782102197Adcuff™885TAWA885TAWA2026-08-26
00634782102203Adcuff™885NWA885NWA2026-08-26
00634782102210Adcuff™886NWA886NWA2026-08-26
00634782101459Prosphyg™760-11ABCAA760-11ABCAA2026-08-25
00634782101633Diagnostix™2101CN2101CN2026-08-25
00634782101848Adscope®603BKAC603BKAC2026-08-25
00634782102098Proscope™664BKKM664BKKM2026-08-25
00634782102104Proscope™664YKM664YKM2026-08-25
00634782102111Proscope™665YKM665YKM2026-08-25
00634782102128Adsoft™660-08BK660-08BK2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782101725Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-03-30
06940211627693MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627709MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627969MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628010MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628027MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628034MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628041MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628058MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628065MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628089MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628096MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628102MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628126MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628133MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628140MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628157MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628164MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628188MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628263MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628317MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628515MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628522MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628539MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628546MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628584MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628669MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628676MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31