FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094248692
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901122
Catalog number
106368
Device description
SPOT VS POWER SUPPLY SET PLUG7 SA
Published
2020-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKORefractometer, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094248692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094248692007320942486927320942486920732094248692

GMDN Terms#

Term, Definition table
TermDefinition
Vision/eye movement analysis systemAn electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.

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
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
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
03615020000014AKR 550ESSILOR INTERNATIONALHKO2026-02-23
03615020000441AKR 800ESSILOR INTERNATIONALHKO2026-02-23
08800019600954Vision ScreenerHuvitz Co., Ltd.HKO2026-02-13
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
B43071000030GoCheck MultiScreenerGobiquity, Inc.HKO2025-11-19
06973211071869Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
06973211071876Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
04571130283381AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PATOPCON CORPORATIONHKO2025-05-12
04571130283367AUTO KERATO-REFRACTOMETER KR-800ATOPCON CORPORATIONHKO2025-04-15
03664188000169VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02
B43071000020GoCheck MultiScreenerGobiquity, Inc.HKO2024-09-23
06971922136037YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2024-08-21
06971922136525YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2024-08-08
04571130282773REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKO2024-08-01
B43071000010GoCheck KidsGobiquity, Inc.HKO2024-07-26
04571130283350AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2024-05-09
04571130283374AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2024-05-09
00860010833292ILLUMINIXIlluminix Industries LLCHKO2024-01-23
04560126268198Chinrest CRX-1000 for REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKO2023-11-16
00732094355970Welch Allyn, Inc.WELCH ALLYN, INC.HKO2023-11-14
08800019600923Auto Ref/Keratometer HRK-8100AHuvitz Co., Ltd.HKO2023-08-24
08906096520076RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDHKO2023-07-06
08906096520083RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDHKO2023-07-06
B43060030010GoCheck KidsGobiquity, Inc.HKO2023-07-06
08800019600503Ref-Keratometer ERK-9100Huvitz Co., Ltd.HKO2023-06-12
03664188000060VisionixLUNEAU TECHNOLOGY OPERATIONSHKO2023-06-08
04250668606052VISUCORE 500 RefractorCarl Zeiss Vision GmbHHKO2023-05-30
04580606431652VisionixRIGHT MFG. CO., LTD.HKO2023-01-05