FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094013979
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901037
Catalog number
20540S
Device description
Welch Allyn 3.5 V Halogen Flat Surface Magnifier with Spectacle Mount; Spectacles Not Included
Published
2023-08-15
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
HJHLoupe, binocular, low power

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJHLoupe, Binocular, Low PowerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094013979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094013979007320940139797320940139790732094013979

GMDN Terms#

Term, Definition table
TermDefinition
Mobile examination/treatment room lightA mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.

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
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
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00814005023304M-2.5 FlipQuality Aspirators, Inc.HJH2025-02-27
00814005023311M-2.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023328M-3.0 FlipQuality Aspirators, Inc.HJH2025-02-27
00814005023335M-3.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023342M-3.5 FlipQuality Aspirators, Inc.HJH2025-02-27
00814005023359M-3.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023458P-3.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023465P-4.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023472P-4.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023496Prism Combo CaseQuality Aspirators, Inc.HJH2025-02-27
00814005023502Q877Quality Aspirators, Inc.HJH2025-02-27
00814005023519Q879Quality Aspirators, Inc.HJH2025-02-27
00814005024196F-3.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024219EP-3.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024226EP-4.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024233EP-4.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024240Q-Optics Loupe CaseQuality Aspirators, Inc.HJH2025-02-27
00814005024318SVRXQuality Aspirators, Inc.HJH2025-02-27
00814005024325BRXQuality Aspirators, Inc.HJH2025-02-27
00814005024332Q-Optics Loupe and Light Combo CaseQuality Aspirators, Inc.HJH2025-02-27
00814005024530FILTER 5151Quality Aspirators, Inc.HJH2025-02-27
00814005024561Eclipse TiQuality Aspirators, Inc.HJH2025-02-27
00814005024578Eclipse-QDNPQuality Aspirators, Inc.HJH2025-02-27
00814005024608FILTER 5801Quality Aspirators, Inc.HJH2025-02-27
00814005024615FILTER PI11Quality Aspirators, Inc.HJH2025-02-27
00814005024622FILTER PI4Quality Aspirators, Inc.HJH2025-02-27
00814005024639FILTER PN10Quality Aspirators, Inc.HJH2025-02-27
00814005024691Side Shield for Q877Quality Aspirators, Inc.HJH2025-02-27
00814005024707Side Shield for Q879Quality Aspirators, Inc.HJH2025-02-27
00814005024769Strap 1Quality Aspirators, Inc.HJH2025-02-27