Duns Number:101394815
Device Description: The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electri The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. This version measures impedance at 10 Hz frequency.
Catalog Number
EIM-105-10Hz
Brand Name
GD
Version/Model Number
Prep-Check 10Hz
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K830876
Product Code
KRC
Product Code Name
Tester, Electrode, Surface, Electrocardiographic
Public Device Record Key
4e56748c-1096-42cb-bf8f-a11d09d0609b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
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. | 10 |