FDA.reportPublic FDA data

Spaulding Client App

Primary DI
B441SMANDCLIENTAPP0
Brand
Spaulding Client App
Company
SPAULDING MEDICAL, LLC
Model
1.2.6.1
Catalog number
SMANDCLIENTAPP
Device description
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
Published
2020-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PYTDevice, Fertility Diagnostic, Contraceptive, Software Application

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYTDevice, Fertility Diagnostic, Contraceptive, Software ApplicationObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B441SMANDCLIENTAPP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116813644
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B441SMIOSCLIENTAPP0Spaulding Client App1.3.6.1SMIOSCLIENTAPP2020-04-02
B441SMWINCLIENTAPP0Spaulding Client App3.0.6.1SMWINCLIENTAPP2020-04-02
B441BTAHA0Spaulding Electrocardiograph2100iQ2017-03-16
B441BTIEC0Spaulding Electrocardiograph2100iQ2017-03-16
B441IQ0Spaulding Electrocardiograph2100iQ2017-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350014630346Natural CyclesNaturalcycles Nordic ABPYT2026-02-27
07350014630353Natural CyclesNaturalcycles Nordic ABPYT2026-02-27
07350014630360Natural CyclesNaturalcycles Nordic ABPYT2026-02-27
07350014630339Natural Cycles ApplicationNaturalcycles Nordic ABPYT2025-05-02
04260749840008Clue Birth ControlBioWink GmbHPYT2022-04-08
07350014630285Natural Cycles ApplicationNaturalcycles Nordic ABPYT2021-11-12
B441SMIOSCLIENTAPP0Spaulding Client AppSPAULDING MEDICAL, LLCPYT2020-04-02
B441SMWINCLIENTAPP0Spaulding Client AppSPAULDING MEDICAL, LLCPYT2020-04-02
07350014630209Natural CyclesNaturalcycles Nordic ABPYT2020-02-09
07350014630124Natural CyclesNaturalcycles Nordic ABPYT2019-03-04
07350014630131Natural CyclesNaturalcycles Nordic ABPYT2019-02-28