FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094087727
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901001
Catalog number
18250
Device description
Welch Allyn Fixation Card Set for Retinoscopes; Qty. 4
Published
2023-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKMRetinoscope, battery-powered
HLIOphthalmoscope, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930023000MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPEWelch Allyn, Inc.1993-06-21HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094087727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094087727007320940877277320940877270732094087727

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic/otologic diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817655023106Welch Allyn, Inc.9011454197342019-10-23
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543855zumaxZumax Medical Co., LTDHKM2026-05-21
06945095543930zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544074zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544159zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544210zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544302zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544470zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544524zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544531zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544562zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544579zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544814zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544852zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544876zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544135zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544197zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
06945095543749zumaxZumax Medical Co., LTDHKM2026-05-18
06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
04053755119967BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
04053755202508BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15