FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094320206
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901131
Catalog number
ELI250C-DCB-ACFAD
Device description
ELI250c 12-Lead Multi-Channel Electrocardiograph - Color LCD display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack paper - A4 with spacer for writer tray); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; Suction electrodes (6) and clamps (4); Ethernet LAN + WLAN (WPA2) + USBD; Standard storage(up to 40 ECGs); DICOM (Bidirectional communication with third party data management system
Published
2019-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094320206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094320206007320943202067320943202060732094320206

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943972Cardio P1Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944276Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
00884838117358patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-05
00884838117273patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117280patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117297patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117303patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117310patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117327patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117334patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117341patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00843997011006Radius VSMMASIMO CORPORATIONDPS2026-02-23
00843997016018Radius VSMMASIMO CORPORATIONDPS2026-02-23
00884838131958Cardiologs PlatformPHILIPS FRANCEDPS2026-02-16
00732094360363Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
00732094360370Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
G697100010010CloudHRV™ SystemInmedix, Inc.DPS2026-01-30
00198953107263MACGe Medical Systems Information Technologies, Inc.DPS2026-01-27
00884838117198patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117204patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117211patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117228patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117259patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117266patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117235patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00884838117242patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00732094237740Welch Allyn, Inc.WELCH ALLYN, INC.DPS2025-09-22