FDA.reportPublic FDA data

Spaulding Electrocardiograph

Primary DI
B441BTAHA0
Brand
Spaulding Electrocardiograph
Company
SPAULDING MEDICAL, LLC
Model
2100iQ
Device description
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECGmanagement solution. (Medical Device Data System) The light weight and portable SpauldingElectrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)information to the WebECG system and receives a report back from the WebECG system.The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ orWindows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable andstrategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a12-lead ECG.
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
B441BTAHA0PrimaryHIBCC0

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
18886077871clientservices@spauldingclinical.com

Regulatory Flags#

DUNS number
116813644
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B441SMANDCLIENTAPP0Spaulding Client App1.2.6.1SMANDCLIENTAPP2020-04-02
B441SMIOSCLIENTAPP0Spaulding Client App1.3.6.1SMIOSCLIENTAPP2020-04-02
B441SMWINCLIENTAPP0Spaulding Client App3.0.6.1SMWINCLIENTAPP2020-04-02
B441BTIEC0Spaulding Electrocardiograph2100iQ2017-03-16
B441IQ0Spaulding Electrocardiograph2100iQ2017-03-14

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