FDA.report

Welch Allyn, Inc.

Primary DI
00732094328844
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901141
Catalog number
H12PLUS-LPD-XXXXX
Device description
H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 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

Related Records

Contact Domains

Product Codes

CodeName
MWJElectrocardiograph, ambulatory (without analysis)

Product Code Classifications

CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094328844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094328844007320943288447320943288440732094328844

GMDN Terms

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

Contacts

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

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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
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