Duns Number:341318999
Device Description: ECG Input Cable with 15-pin D-Sub Plug to 1.8m Trunk Cable and 1m Leads with Medi-Clip, AH ECG Input Cable with 15-pin D-Sub Plug to 1.8m Trunk Cable and 1m Leads with Medi-Clip, AHA color coding (RA-White, LL-Red, RL-Green)Special Edition for GE Health Care
Catalog Number
C3-C-U-LL-D
Brand Name
Norav Medical
Version/Model Number
C3-C-U-LL-D
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
9fc88ed4-f2ec-42de-9d92-16a471d4161c
Public Version Date
April 06, 2020
Public Version Number
2
DI Record Publish Date
December 05, 2019
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. | 46 |