FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094322927
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901134
Catalog number
ESCRIBE-BEX-CXACA
Device description
E-Scribe ECG Data Management Server - Enterprise system; Italian system language; Software kit; No modem connections; Customizable worklists; Both Expanded output capabilities (e-mail, fax, XML) and Advanced criteria (demographics, measurements); VERITAS
Published
2019-07-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930558000MORTARA INSTRUMENT, INC. E-SCRIBEMortara Instrument, Inc.1993-04-27DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094322927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094322927007320943229277320943229270732094322927

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms 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 electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, 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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094323931Welch Allyn, Inc.901139S2-P-AXX-XXX2023-08-25
00732094272222Welch Allyn, Inc.90114533193-001-512019-09-26
00732094262551Welch Allyn, Inc.901011SCNODE-DEB-CXXXX2019-09-25
00732094288773Welch Allyn, Inc.9011441081912020-11-10
00732094288780Welch Allyn, Inc.9011441081902020-11-10
00732094272086Welch Allyn, Inc.90109541000-032-572020-02-19
00732094272154Welch Allyn, Inc.90114533193-106-532019-09-26
00732094272161Welch Allyn, Inc.90114533193-106-522019-09-26
00732094272178Welch Allyn, Inc.90114533193-106-512019-09-26
00732094271782Welch Allyn, Inc.901007ACC-ELI280-A2019-07-24
00732094265125Welch Allyn, Inc.901134ESWK-AEB-BXXXX2019-09-17
00732094271812Welch Allyn, Inc.901095ACC-BUR280-B2019-09-13
00732094272116Welch Allyn, Inc.90109541000-031-572019-09-13
00732094271768Welch Allyn, Inc.901007ACC-ELI380-A2019-09-12
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22

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