Duns Number:177939027
Device Description: Covidien Disposable 6 Lead System For Use with GE Apex™Pro FH Telemetry System-Direct Conn Covidien Disposable 6 Lead System For Use with GE Apex™Pro FH Telemetry System-Direct Connect
Catalog Number
-
Brand Name
Covidien
Version/Model Number
33126
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 10, 2019
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
b6c386bf-d72c-40ae-8797-631d4d1bcea6
Public Version Date
March 19, 2021
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
30817357020848
Quantity per Package
10
Contains DI Package
10817357020844
Package Discontinue Date
March 19, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |