Duns Number:305682023
Device Description: Ambu White Sensor 4440M Electrod with wet gel and cloth backing. With center snap and PVC Ambu White Sensor 4440M Electrod with wet gel and cloth backing. With center snap and PVC free. Radiolucent and MR Conditional. Packaging: 30 pouch/300 inner box/ 3000 carton
Catalog Number
4440M
Brand Name
Ambu WhiteSensor 4440MECG Electrodes
Version/Model Number
4440M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 06, 2021
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
de1dfbce-abed-4828-b244-dd7faed3ae9c
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
05060038512239
Quantity per Package
10
Contains DI Package
05060038510716
Package Discontinue Date
April 06, 2021
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 |