Duns Number:055363428
Device Description: Stand alone software that provides a reliable and consistent method for Advanced Cardiac L Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems.
Catalog Number
-
Brand Name
ZOLL Code Writer
Version/Model Number
9658-0304-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132488
Product Code
DXJ
Product Code Name
Display, Cathode-Ray Tube, Medical
Public Device Record Key
4bbabdfb-2592-4c6d-8f07-c4bb2140a67b
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
March 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |