Duns Number:305682023
Device Description: Ambu White Sensor 7841P Electrod with Bio-Tack sticky gel and cleartape backing. With cent Ambu White Sensor 7841P Electrod with Bio-Tack sticky gel and cleartape backing. With center snap and PVC free. Radiolucent and MR Conditional. Packaging: 30 pouch/300 inner box/ 3000 carton
Catalog Number
7841P
Brand Name
Ambu WhiteSensor 7841PECG Electrodes
Version/Model Number
7841P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 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
6514f7c3-eb06-4c61-ad4d-6ba4877412dc
Public Version Date
January 10, 2022
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
05707480129836
Quantity per Package
12
Contains DI Package
05707480129829
Package Discontinue Date
January 09, 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 |