Duns Number:055363428
Device Description: Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads t Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI.
Catalog Number
-
Brand Name
RescueNet 12-Lead
Version/Model Number
8700-010001-01
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
K121865
Product Code
MSX
Product Code Name
System,Network And Communication,Physiological Monitors
Public Device Record Key
4e4ddef6-37a7-4538-b6b2-8a688c4e7fc5
Public Version Date
July 06, 2018
Public Version Number
3
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 |