Duns Number:305682023
Device Description: Ambu White Sensor 0415M Electrod with solid gel and polymer backing and tab connector. Rad Ambu White Sensor 0415M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/ 500 inner box/ 5000 carton
Catalog Number
0415M
Brand Name
Ambu WhiteSensor 0415M BIOTABSECG Electrodes
Version/Model Number
0415M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2022
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
1d62765b-360b-44cd-8a1b-d09ab0230dcf
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
05060038511089
Quantity per Package
5
Contains DI Package
05060038514479
Package Discontinue Date
May 01, 2022
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 |