Duns Number:790605856
Device Description: Preattached Leadwire electrode, Medium Radiolucent carbon AAMI color 45cm/18" leadwires wi Preattached Leadwire electrode, Medium Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket rectangular 33cm x 22cm cloth backingwith Ag/AgCl sensor, 3/pouch, 300/case.
Catalog Number
13952B
Brand Name
ECG Cables and Leadsets
Version/Model Number
Preattached Leadwire electrode, Medium
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
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
DRY
Product Code Name
MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
Public Device Record Key
3a7a85a6-295d-414d-a435-5f002456c583
Public Version Date
September 21, 2022
Public Version Number
9
DI Record Publish Date
December 27, 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 |