FDA.report

Diagnostix™

Primary DI
00634782088231
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
5611X-3457EUW
Catalog number
5611X-3457EUW
Device description
Adstation Oto-X/Derm,429,Clock Aner/Spec Disp, EU, WB
Published
2018-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IBJLight, Microscope

Product Code Classifications

CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782088231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782088231006347820882316347820882310634782088231

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00634782902636Adcuff™ 920-011N920-011N2026-02-23
00634782101695ADC®381N381N2026-02-20
00634782903213ADC®380N380N2026-02-20
00634782903190Advantage™611561152025-11-24
00634782903152Advantage™611261122025-09-19
00634782903169Advantage™612161212025-09-19
00634782903176Advantage™6121SA6121SA2025-09-19
00634782903183Advantage™6121X6121X2025-09-19
00634782903091Adtemp™ 424N-40424N-402025-02-05
00634782603106Adtemp™ 424N-200424N-2002025-02-05
00634782903039Adtemp™ 424N424N2025-01-29
00634782600402Adscope®608LPST608LPST2023-01-11
00634782600600Adscope®600IMCA600IMCA2023-01-10
00634782600617Adscope®600IST600IST2023-01-10
00634782600624Adscope®601IMCA601IMCA2023-01-10
00634782600631Adscope®601IST601IST2023-01-10
00634782600648Adscope®601RGBK601RGBK2023-01-10
00634782600655Adscope®608RGBK608RGBK2023-01-10
00634782600662Adscope®608RGW608RGW2023-01-10
00634782600679Adscope®606RGBK606RGBK2023-01-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08052691050002NED-DP Nano Eye Device for Digital PathologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
08052691050019NED-DH Nano Eye Device for Digital HematologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
GYNXMI60000GynexGYNEX CORPORATIONIBJ2023-12-20
04260158450065FotoFinder medicamFotoFinder Systems GmbHIBJ2023-08-07
04260158450089FotoFinder leviacamFotoFinder Systems GmbHIBJ2023-08-07
00664816002391LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002407LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002414LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002421LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002759LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00852728008864SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860009669192SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860010027707SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00850147000094MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
85014700009486MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
00304040043400Henry ScheinHENRY SCHEIN, INC.IBJ2022-04-22
00304040043417Henry ScheinHENRY SCHEIN, INC.IBJ2022-04-22
00304040043424Henry ScheinHENRY SCHEIN, INC.IBJ2022-04-22
00304040043431Henry ScheinHENRY SCHEIN, INC.IBJ2022-04-22
00304040043448Henry ScheinHENRY SCHEIN, INC.IBJ2022-04-22
00664816000908LW Scientific, IncLW SCIENTIFIC, INC.IBJ2021-04-09
00664816000922LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000939LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000946LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000953LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816002568LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000861LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-08
00664816000878LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-08
00664816000885LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-08
00664816000892LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-08