Duns Number:800214827
Device Description: Amplification and signal processing module designed to interface with CardioCommand esopha Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (unpackaged unit).
Catalog Number
0104-9999
Brand Name
Model 3
Version/Model Number
Re-manufactured, unpackaged
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
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
P860008,P860008
Product Code
LPA
Product Code Name
System, Esophageal Pacing
Public Device Record Key
87cf5698-406e-45a7-936e-6b56dc0d74ef
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 2015
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. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 17 |