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 ( SEER 1000 recorder).
Catalog Number
2104812-001
Brand Name
ECG Cable for SEER 1000
Version/Model Number
5 Leads, 105 cm, IEC Color Code
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130785
Product Code
MWJ
Product Code Name
Electrocardiograph,Ambulatory(Without Analysis)
Public Device Record Key
5a942b56-dd9c-4e2e-83e6-2632bb264bb4
Public Version Date
September 20, 2019
Public Version Number
1
DI Record Publish Date
September 12, 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. | 47 |