FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094296341
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901012
Catalog number
11093-003-50
Device description
SOFTWARE MONITIOR WAVEFORM VIEWER V2.1.0
Published
2019-06-11
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
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141811000MORTARA MONITORING WAVEFORM VIEWERMortara Instrument, Inc.2014-11-19MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094296341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094296341007320942963417320942963410732094296341

GMDN Terms#

Term, Definition table
TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

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

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