FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094323214
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901124
Catalog number
RV700TU-B
Device description
RetinaVue 700 Imager Set – Trade-Up
Published
2019-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJZCamera, ophthalmic, general-use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094323214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094323214007320943232147320943232140732094323214

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

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
false
Serial number
true
Manufacturing date on label
false
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
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22
00732094322927Welch Allyn, Inc.901134ESCRIBE-BEX-CXACA2019-07-22
00732094322934Welch Allyn, Inc.901134ESCRIBE-BEX-CXAAA2019-07-22
00732094322941Welch Allyn, Inc.901134ESCRIBE-BAX-DXACX2019-07-22
00732094322958Welch Allyn, Inc.901134ESCRIBE-BAX-DXACB2019-07-22
00732094322965Welch Allyn, Inc.901134ESCRIBE-BAX-CXXXX2019-07-22
00732094322972Welch Allyn, Inc.901134ESCRIBE-BAX-CXACB2019-07-22
00732094322989Welch Allyn, Inc.901134ESCRIBE-BAX-CXACA2019-07-22
00732094322996Welch Allyn, Inc.901134ESCRIBE-BAX-CXAAX2019-07-22
00732094323009Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXX2019-07-22
00732094323016Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXA2019-07-22
00732094323023Welch Allyn, Inc.901134ESCRIBE-AEX-CXAXA2019-07-22
00732094323030Welch Allyn, Inc.901134ESCRIBE-AEX-CXAAA2019-07-22
00732094323047Welch Allyn, Inc.901134ESCRIBE-AAX-DXXXX2019-07-22
00732094323054Welch Allyn, Inc.901134ESCRIBE-AAX-CXXXX2019-07-22

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Primary DI, Brand, Company table
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00860012447138EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447145EyeCasterInnovations Lightx IncPJZ2025-11-12
06973211070619Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071500Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071517Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
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00850067214281identifeye Camera System, reconditionedIdentifeye Health Inc.PJZ2025-07-07
06976107790301AirdocChangsha Airdoc Health Technology Co., Ltd.PJZ2024-09-27
07908616100097Eyer 2 BasicPHELCOM TECHNOLOGIES SAPJZ2024-09-23
00860011978305EntireEye PortableRETIVUE, LLCPJZ2024-07-18
00811608014708Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00811608014739Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00860010826812Oivi Opthalmic Fundus CameraOivi ASPJZ2024-01-15
00853501008002Spect Ophthalmic CameraSpect Inc.PJZ2023-08-10
10860000249543Verily Retinal CameraVERILY LIFE SCIENCES LLCPJZ2023-05-24
07908616100042EyerPHELCOM TECHNOLOGIES SAPJZ2023-04-27
08056389701405ME-CHECK 4ESPANSIONE MARKETING SPAPJZ2023-04-05
00811608013770Volk VistaViewVOLK OPTICAL INC.PJZ2022-11-16
00850038195229Eli EzerU.S. OPHTHALMIC, L.L.C.PJZ2022-11-03
06945087500088MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.PJZ2022-11-02
00628678036017WRI-1Cellview Imaging Inc.PJZ2022-09-08
00628678036055WRI-1Cellview Imaging Inc.PJZ2022-09-08
06973211070008Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2022-06-08
08906096520052RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDPJZ2022-01-31