Duns Number:305682023
Device Description: White Sensor 5050-00-A/50 ECG electrode Wet gel, foam backing and offset connector Pouch 5 White Sensor 5050-00-A/50 ECG electrode Wet gel, foam backing and offset connector Pouch 50 pcs. /box 1000 pcs / carton 6000 pcs
Catalog Number
5050-00-S/50
Brand Name
Ambu WhiteSensor 5050
Version/Model Number
5050-00-S/50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2020
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)
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
66541dbb-8dce-4ce5-b988-05e56183c808
Public Version Date
September 10, 2020
Public Version Number
2
DI Record Publish Date
August 05, 2019
Package DI Number
05707480136827
Quantity per Package
6
Contains DI Package
05707480136810
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 |