Duns Number:002111896
Device Description: SET OF 12 PRE-WIRED RT ADULT ELECTRODES
Catalog Number
32028779
Brand Name
Vermed
Version/Model Number
IP-Set 12 RT Adult-US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 2019
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
18c28483-fe5d-4d44-967a-be8a94d1a209
Public Version Date
June 04, 2019
Public Version Number
4
DI Record Publish Date
October 30, 2017
Package DI Number
50009336008877
Quantity per Package
12
Contains DI Package
30009336008873
Package Discontinue Date
June 03, 2019
Package Status
Not 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 |