Duns Number:249968140
Device Description: Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Mu Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators.– tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers– see www.datrend.com for complete information
Catalog Number
8000-440
Brand Name
Datrend
Version/Model Number
Phase3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K062099
Product Code
DRL
Product Code Name
Tester, Defibrillator
Public Device Record Key
976bd78c-bb0f-4295-b195-20205f049bb7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |