FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094082739
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901025
Catalog number
26530
Device description
3.5v Nasal Illuminator complete with 9mm Specula
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00732094082739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094082739007320940827397320940827390732094082739

GMDN Terms#

Term, Definition table
TermDefinition
Visible-light skin transilluminatorAn electrically-powered device intended to use 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 a healthcare professional 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850038195564EZ-TRI-3600U.S. OPHTHALMIC, L.L.C.HJN2025-02-19
07898915128789VF1000LED Vein locatorFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAHJN2024-06-07
00850064466348VF1000LED 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
04260114140214ASTODIAStihler Electronic GmbHHJN2023-07-18
00850018561099Wee Sight Transilluminator INTERNATIONAL BIOMEDICAL, LTD.HJN2023-06-20
00732094084207Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-04-25
00732094082722Welch Allyn, Inc.WELCH ALLYN, INC.HJN2021-07-12
00812594012716NeoGlo SleeveNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013065NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013072NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013089NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00860003720509ESU TRANSILLUMINATORESU LIMITED LIABILITY PARTNERSHIPHJN2020-05-01
B853NT010VenoscopeVENOSCOPE, LLCHJN2020-03-13
B853VT030VenoscopeVENOSCOPE, LLCHJN2020-03-13
00732094175165Welch Allyn, Inc.WELCH ALLYN, INC.HJN2020-01-16
04719873921447LUMINDEXDENTMATE TECHNOLOGY CO., LTD.HJN2019-07-17
04719873921775LUMINDEXDENTMATE TECHNOLOGY CO., LTD.HJN2019-07-17
04719873921782LUMINDEXDENTMATE TECHNOLOGY CO., LTD.HJN2019-07-17
00723896009048Lumindex 3 LED TransilluminatorPRACTICON, INC.HJN2018-07-20
00723896009079Lumindex 3 LED Transilluminator Standard 3mm Light GuidePRACTICON, INC.HJN2018-07-20
00812594012662NeoGlo - Bright Pink (N555BP-B)NEOTECH PRODUCTS, INC.HJN2018-01-16
00812594012679NeoGlo - Aqua (N555AQ-B)NEOTECH PRODUCTS, INC.HJN2018-01-16
00812594012686NeoGlo - Violet (N555VL-B)NEOTECH PRODUCTS, INC.HJN2018-01-16
00812594012594NeoGlo - Blue (N555BL-B)NEOTECH PRODUCTS, INC.HJN2017-09-05