Spaulding Client App SMIOSCLIENTAPP

GUDID B441SMIOSCLIENTAPP0

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 IOS platform.

SPAULDING MEDICAL

Electrocardiographic long-term ambulatory recording analyser application software
Primary Device IDB441SMIOSCLIENTAPP0
NIH Device Record Key69ce381d-db42-475b-897a-829a5a894493
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpaulding Client App
Version Model Number1.3.6.1
Catalog NumberSMIOSCLIENTAPP
Company DUNS116813644
Company NameSPAULDING MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB441SMIOSCLIENTAPP0 [Primary]

FDA Product Code

PYTDevice, Fertility Diagnostic, Contraceptive, Software Application

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

On-Brand Devices [Spaulding Client App]

B441SMWINCLIENTAPP0Spaulding Client Application is a web based application for trained users of the Spaulding Medic
B441SMIOSCLIENTAPP0Spaulding Client Application is a web based application for trained users of the Spaulding Medic
B441SMANDCLIENTAPP0Spaulding Client Application is a web based application for trained users of the Spaulding Medic

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