Duns Number:305682023
Device Description: White Sensor 3245D/RT/60 ECG electrode With Dual Connector; clip and stud. Wet gel and foa White Sensor 3245D/RT/60 ECG electrode With Dual Connector; clip and stud. Wet gel and foam material, and Radiolucent and MRI conditional Pouch 60 pcs. /box 1200 pcs / carton 7200 pcs
Catalog Number
3245D/RT/60
Brand Name
Ambu WhiteSensor 3245D/RT
Version/Model Number
3245D/RT/60
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2020
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
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
c0db2868-3917-4be9-8f44-8504b61529bc
Public Version Date
September 10, 2020
Public Version Number
2
DI Record Publish Date
August 05, 2019
Package DI Number
05707480136414
Quantity per Package
20
Contains DI Package
05707480136407
Package Discontinue Date
September 10, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |