Duns Number:071595540
Device Description: POSITRACE RTL, ADULT DIAPHORIC ECG ELECTRODE
Catalog Number
1870C-005
Brand Name
POSITRACE
Version/Model Number
1870C-005
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091856,K091856,K091856
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
016ecfb6-1574-4eb9-982e-f11002b359ee
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405059223
Quantity per Package
600
Contains DI Package
10653405059226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |