AccessGUDID - DEVICE: Spaulding Client App (B441SMIOSCLIENTAPP0)

GUDID

Device Identifier (DI) Information

Brand Name: Spaulding Client App
Version or Model: 1.3.6.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMIOSCLIENTAPP
Company Name: SPAULDING MEDICAL

Primary DI Number: B441SMIOSCLIENTAPP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116813644 *Terms of Use

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 IOS platform.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41651	Electrocardiographic long-term ambulatory recording analyser application software	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69ce381d-db42-475b-897a-829a5a894493
Public Version Date: April 10, 2020
Public Version Number: 1
DI Record Publish Date: April 02, 2020