Duns Number:055363428
Device Description: Stand alone software used to collect, store and print patient data on a variety of commerc Stand alone software used to collect, store and print patient data on a variety of commercial OTS hardware.
Catalog Number
-
Brand Name
RescueNet ePCR
Version/Model Number
TMUL
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
K103473
Product Code
DXJ
Product Code Name
Display, Cathode-Ray Tube, Medical
Public Device Record Key
1f357331-6706-4bf3-98d5-57fc6c853153
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 |