FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094326079
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901006
Catalog number
9293-024-51
Device description
Resting ECG patient cable with flat connector
Published
2023-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094326079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094326079007320943260797320943260790732094326079

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or 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.

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00732094354959Welch Allyn, Inc.901130ELI230-ADA-AAAAX2026-06-09

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
00850067829003LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829010LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829027LIFEECaf Medical Solutions, IncMLD2025-02-12
00850067829041LIFEECaf Medical Solutions, IncMLD2025-02-12
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