Duns Number:790605856
Device Description: Preattached leadwire electrode, square. Metallic copper IEC color 45cm/18" lead- wires wit Preattached leadwire electrode, square. Metallic copper IEC color 45cm/18" lead- wires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/AgCl sensor, 3/pouch, 300/case.
Catalog Number
13953D
Brand Name
ECG Cables and Leadsets
Version/Model Number
PREATTACHED LEADWIRE ELECTRODE, SQUARE.
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
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
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
76ba9f23-bd3c-4938-8e2e-20ff9741fecb
Public Version Date
August 24, 2022
Public Version Number
10
DI Record Publish Date
December 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |