FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094336740
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901087
Catalog number
719-3
Device description
Li-Ion Plus USB Handle for Desk Charger
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
HLSExophthalmometer
NOIStand, instrument, ophthalmic, battery powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLSExophthalmometerOphthalmic1
NOIStand, Instrument, Ophthalmic, Battery PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K77190000071110 DESK CHARGERWelch Allyn, Inc.1977-11-09HLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094336740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094336740007320943367407320943367400732094336740

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

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
00732094344004Welch Allyn, Inc.WELCH ALLYN, INC.NOI2023-09-07
00732094140323Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-23
00732094140576Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-23
00732094139266Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094139341Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094139365Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094139969Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094140293Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094140309Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-18
00732094077599Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
00732094077636Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
00732094078572Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
00732094078596Welch Allyn, Inc.WELCH ALLYN, INC.HLS2023-08-17
04049584007582Mirror Exophthalmometer acc. to HertelOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLS2022-12-02
04049584007599Mirror Exophthalmometer acc. to NaugleOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLS2022-12-02
B091161040Luedde ExophthalmometerGulden Ophthalmics Inc.HLS2022-11-28
00732094345872Welch Allyn, Inc.WELCH ALLYN, INC.NOI2022-08-05
00732094139389Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-12-08
00732094338409Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338416Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338423Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338430Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338447Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338454Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338461Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094338478Welch Allyn, Inc.WELCH ALLYN, INC.NOI2020-08-20
00732094338478Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-20
00732094248937Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-08-03
00732094138979Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-06-18
00732094139884Welch Allyn, Inc.WELCH ALLYN, INC.HLS2020-06-18