FDA.reportPublic FDA data

Amico Diagnostic Station

Primary DI
00697077002343
Brand
Amico Diagnostic Station
Company
Amico Diagnostic Incorporated
Model
DS-UV1-CHFL-DXX
Device description
Diagnostic Station -Oph Hal & Oto LED, Spec. Dispenser with Vert. Rail MountsDiagnostic Station Wall Mount, Ophthal Halogen & Oto LED (DI 00697077001308)
Published
2018-03-22
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
ERAOtoscope
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00697077002343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077002343006970770023436970770023430697077002343

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
1-877-264-2697info@amico-accessories.com

Regulatory Flags#

DUNS number
203163290
Device count
1
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
00697077001254Amico Diagnostic StationDS-UDM-CHFH-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
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20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
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10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
17290018446154Nonagon N9+NONAGON LTDERA2022-09-28
27290018446151Nonagon N9+ SmartExamNONAGON LTDERA2022-09-28
00860003469828hearXHEARX GROUP (PTY) LTDERA2022-05-30
M368122711LABTRONGF HEALTH PRODUCTS, INC.ERA2020-09-15
H65811255271Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
H65811255281Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
10304040029203Henry ScheinHENRY SCHEIN, INC.ERA2018-12-21
10304040029197Henry ScheinHENRY SCHEIN, INC.ERA2018-09-24