FDA.report

Welch Allyn, Inc.

Primary DI
00732094337204
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901129
Catalog number
ELI150C-ADB-ACCBX
Device description
ELI150c 12-Lead Multi-Channel Electrocardiograph - Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module (includes 1 starter pack paper - Z-fold, 4.25" x 5.5"); current software; International power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and Pediatric Interpretation; Suction electrodes (6) and clamps (4); Ethernet LAN + USBD; Expanded storage (up to 200 ECGs);
Published
2020-06-12
Public version status
Update
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
DPSElectrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094337204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094337204007320943372047320943372040732094337204

GMDN Terms

TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

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
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

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