Welch Allyn, Inc.

Primary DI
00732094344011
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901090
Catalog number
71-XM3LXE
Device description
Welch Allyn MacroView Plus iExaminer Kit
Published
2020-12-08
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
ERAOTOSCOPE
HLIOphthalmoscope, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003376000WELCH ALLYN 11800 OPTHALMOSCOPEWelch Allyn, Inc.2001-01-25HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094344011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094344011007320943440117320943440110732094344011

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
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05
00732094209921Welch Allyn, Inc.90105874CE-B2017-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
17290018446154Nonagon N9+NONAGON LTDERA2022-09-28
27290018446151Nonagon N9+ SmartExamNONAGON LTDERA2022-09-28
M368122711LABTRONGF HEALTH PRODUCTS, INC.ERA2020-09-15
H65811255271Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
H65811255281Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
10304040029203Henry ScheinHENRY SCHEIN, INC.ERA2018-12-21
10304040029197Henry ScheinHENRY SCHEIN, INC.ERA2018-09-24
10381780403234Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONERA2018-08-16
10381780403289Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONERA2018-08-16
10381780403869Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONERA2018-08-16
10381780479369Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONERA2018-08-16
00634782087753Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087760Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087777Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087784Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087791Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087807Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087814Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087821Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087838Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087845Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12
00634782087852Diagnostix™AMERICAN DIAGNOSTIC CORPERA2018-01-12