FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094034813
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901006
Catalog number
008-0522-00
Device description
ECG Cable, 5 Attached Leads Snap, AAMI, 4OX/8O2, 4'
Published
2021-04-22
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
MLDMONITOR, ST SEGMENT WITH ALARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLDMonitor, St Segment With AlarmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972121000ACUITY CENTRAL STATIONProtocol Systems, Inc.1997-11-07MLD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094034813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094034813007320940348137320940348130732094034813

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

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
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17
00732094183948Welch Allyn, Inc.90102211820-L2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
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00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-07-13
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMLD2026-04-15
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-03-09
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-11-17
06944413838406Patient Monitor Edan Instruments, Inc.MLD2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.MLD2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.MLD2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2025-05-06
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00850067829058LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829065LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829072LIFEECaf Medical Solutions, IncMLD2025-02-12
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MLD2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgMLD2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgMLD2024-11-27