Duns Number:116813644
Device Description: The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic E 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.
Catalog Number
-
Brand Name
Spaulding Electrocardiograph
Version/Model Number
2100iQ
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
f72defec-df04-4949-bf61-dcc0ccc59701
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
March 16, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |