FDA.reportPublic FDA data

Amico Diagnostic Station

Primary DI
00697077001254
Brand
Amico Diagnostic Station
Company
Amico Diagnostic Incorporated
Model
DS-UDM-CHFH-DAO
Device description
Diag. Station -Oph & Oto, Spec. Dis., Aneroid & Adlt Cuff, Therm, Direct MountAdult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769)Diagnostic Station Wall Mount, Ophthal & Oto Halogen (DI 00697077001285)3000 AD Electronic Thermometer (DI 10192253006421)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff
ERAOtoscope
FLLThermometer, Electronic, Clinical
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2
ERAOtoscopeEar, Nose, Throat1
FLLContinuous Measurement ThermometerGeneral Hospital2
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00697077001254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077001254006970770012546970770012540697077001254

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscope, line-poweredA mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-462-6426info@amico-accessories.com

Regulatory Flags#

DUNS number
203163290
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00697077003180Amico Diagnostic CuffCR2-LF09G-2QFQF2026-07-07
00697077003197Amico Diagnostic CuffCR2-LF10B-2QFQF2026-07-07
00697077003203Amico Diagnostic CuffCR2-LF13W-2QFQF2026-07-07
00697077003210Amico Diagnostic CuffCR2-LF11N-2QFQF2026-07-07
00697077003081Amico Diagnostic StationDS-KDM-CLFL-DAO 2025-07-14
00697077002565Amico Diagnostic StationDS-UF2-CHFH-DAO2020-07-17
00697077002527Amico Diagnostic StationDS-UF3-CHFH-DAO2020-02-24
00697077002480Amico Diagnostic RollstandDS-UR1-CLFL-DAO2019-03-26
00697077001070Amico Diagnostic StationDS-UA1-CHFH-DAO2016-09-24
00697077001100Amico Diagnostic StationDS-UA1-CHFH-DLO2016-09-24
00697077001124Amico Diagnostic StationDS-UA1-CHFH-DXO2016-09-24
00697077001155Amico Diagnostic StationDS-UA1-CLFL-DAO2016-09-24
00697077001162Amico Diagnostic StationDS-UA1-CLFL-DLO2016-09-24
00697077001209Amico Diagnostic Wallboard DS-UBW-CHFH-DAO2016-09-24
00697077001230Amico Diagnostic Wallboard DS-UBW-CLFL-DAO2016-09-24
00697077001322Amico Diagnostic StationDS-UDM-CLFL-DAO2016-09-24
00697077001377Amico Diagnostic Wallboard DS-UDN-CHFH-DAO2016-09-24
00697077001391Amico Diagnostic StationDS-UE1-CHFH-DLO2016-09-24
00697077001421Amico Diagnostic StationDS-UF1-CHFH-DAO2016-09-24
00697077001438Amico Diagnostic StationDS-UF1-CHFH-DLO2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
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00859140003217DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782102456Diagnostix™AMERICAN DIAGNOSTIC CORPERA2026-10-06
00634782102517ADCAMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00634782102159Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102166Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102173Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102197Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102203Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102210Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
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04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
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04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
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