Duns Number:007941230
Device Description: Electrode Defibrillation Electrocardiogram Radiolucent Vinyl Laminated Foam Conductive Foi Electrode Defibrillation Electrocardiogram Radiolucent Vinyl Laminated Foam Conductive Foil Adhesive Hydrogel Pacing Equal To Phillips Dp2 Amp Dp6 Amp M3713A Adult Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
MC1710H
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
-
Product Code
MLN
Product Code Name
Electrode, electrocardiograph, multi-function
Public Device Record Key
ea6fb5b3-4270-476e-84e8-e8e3f7735258
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 15, 2018
Package DI Number
50885632116627
Quantity per Package
10
Contains DI Package
10885632116629
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |