FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094328820
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901141
Catalog number
H12PLUS-MPC-XXXXX
Device description
H12+ Standard 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
Published
2023-08-25
Public version status
New
Distribution status
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
MWJElectrocardiograph, ambulatory (without analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094328820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094328820007320943288207320943288200732094328820

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

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
true
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
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201103SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201127SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
00840241600313ASSURE Wearable ECGKestra Medical Technologies, Inc.MWJ2024-09-18
00840241600320Battery Kestra Medical Technologies, Inc.MWJ2024-09-18
00840241600337System CableKestra Medical Technologies, Inc.MWJ2024-09-18
10841522127274Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129698Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129728Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129742Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129810Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
30841522125557EVOSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-04-22
10841522129209Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-03-19
10841522128769Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-03-15
B635BIOTRESPR0Biotres ProBIOTRICITY INCMWJ2024-03-07
10841522129674Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
10841522129704Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
10841522129711Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
08800159500022S-Patch ExLWellysis Corp.MWJ2024-02-21
04250903202636SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01
04250903202643SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01