Duns Number:002111896
Device Description: Electrocardiographic recording paper
Catalog Number
32019460
Brand Name
Vermed
Version/Model Number
SIS RXL 63031
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSF
Product Code Name
Recorder, Paper Chart
Public Device Record Key
1cefc5a0-87b2-4537-97e8-5c5f93d78aa4
Public Version Date
October 24, 2018
Public Version Number
1
DI Record Publish Date
September 23, 2018
Package DI Number
50009336001434
Quantity per Package
5
Contains DI Package
00009336001439
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 |