Duns Number:002111896
Device Description: SET OF 3 PRE-WIRED RT ADULT ELECTRODES
Catalog Number
32028777
Brand Name
Vermed
Version/Model Number
IP-Set M3 RT Adult-US
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
K101685,K101685,K101685
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
9591b887-e120-471a-a316-2729ffbf69e3
Public Version Date
June 12, 2019
Public Version Number
1
DI Record Publish Date
June 04, 2019
Package DI Number
23700506307344
Quantity per Package
1920
Contains DI Package
13700506307347
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 | 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 |