FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094074109
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901067
Catalog number
44400
Device description
Welch Allyn Green Series 300 General Exam Light with Mobile Stand; One White LED, 20,000 LUX @ 12 in/30 cm, 5,500° K; Touchless Controls; 100-240 V, 50-60 Hz AC, IEC Plug Type-B
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCWTransformer, endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCWTransformer, EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771864000WALL TRANSFORMERS 74710 & 74910Welch Allyn, Inc.1977-11-22GCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094074109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094074109007320940741097320940741090732094074109

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment room lightA fixed 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) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

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
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
00732094072709Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073362Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073621Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073683Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073898Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094147629Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094144086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094136715Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136722Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136760Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094174021Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00304040090664Henry ScheinHENRY SCHEIN, INC.GCW2021-04-23
00732094342055Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342079Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342130Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342154Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342031Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342048Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342062Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342093Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342116Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342123Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342147Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342161Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342178Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342185Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094341805Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10
00732094341812Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10