Duns Number:002111896
Device Description: 3 per pack, 30 per box (12 packs), 8 boxx per case of 480 electrodes
Catalog Number
A10006-3-30
Brand Name
Guardian™
Version/Model Number
A10006-3-30
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"
Yes
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
a45bf000-6f9e-467c-b1f3-6c6843e0f361
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 07, 2017
Package DI Number
10813150020418
Quantity per Package
8
Contains DI Package
00813150020411
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |