Duns Number:331682898
Device Description: The cable is intended to be used to conduct electrical signals from a patient's heart, via The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
Catalog Number
2014606-039
Brand Name
ECG Leadwire Set for CM 3000 Series
Version/Model Number
7 Leads, 60 cm, Colors: Red, Brown, Black, White, Green, Blue, Orange
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)
Yes
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
K022540
Product Code
DSH
Product Code Name
Recorder, Magnetic Tape, Medical
Public Device Record Key
46d6b1bc-e4a0-411a-b7f6-1c97fe8a7ae2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
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. | 47 |