FDA.reportPublic FDA data

Amico Diagnostic Illuminator

Primary DI
00697077003166
Brand
Amico Diagnostic Illuminator
Company
Amico Diagnostic Incorporated
Model
DH-W35-LL
Device description
Larynx Illuminator, with LED bulb
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJNTransilluminator, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00697077003166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077003166006970770031666970770031660697077003166

GMDN Terms#

Term, Definition table
TermDefinition
Visible-light skin transilluminator, reusableAn electrically-powered, noninvasive device intended to produce visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-877-264-2697info@amico-accessories.com

Regulatory Flags#

DUNS number
203163290
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00697077001438Amico Diagnostic StationDS-UF1-CHFH-DLO2016-09-24
00697077001469Amico Diagnostic StationDS-UF1-CLFL-DAO2016-09-24
00697077001476Amico Diagnostic StationDS-UF1-CLFL-DLO2016-09-24
00697077001490Amico Diagnostic Wallboard DS-ULG-CHFH-DAO2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543787zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544050zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544678zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544692zumaxZumax Medical Co., LTDHJN2026-05-21
B945BERAI0BernellBernellHJN2026-05-02
B945MTBIFL0BernellBernellHJN2026-05-02
B945MTBIH20BernellBernellHJN2026-05-02
00697077003173Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2025-07-17
00850064466348VF1000LED Vein locatorFABINJECT LLCHJN2025-03-02
00850038195564EZ-TRI-3600U.S. OPHTHALMIC, L.L.C.HJN2025-02-19
07898915128789VF1000LED Vein locatorFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAHJN2024-06-07
00732094074130Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074185Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074192Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082708Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082715Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082739Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
04260114140214ASTODIAStihler Electronic GmbHHJN2023-07-18
00850018561099Wee Sight Transilluminator INTERNATIONAL BIOMEDICAL, LTD.HJN2023-06-20
00732094084207Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-04-25
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2022-12-21
00732094082722Welch Allyn, Inc.WELCH ALLYN, INC.HJN2021-07-12
10812594013000NeoGlo DisposableNeotech Products LLCHJN2021-05-20
10812594013062NeoGlo DisposableNeotech Products LLCHJN2021-05-20
00812594012716NeoGlo®Neotech Products LLCHJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013065NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20