Duns Number:002111896
Device Description: Electrocardiographic recording paper
Catalog Number
32027852
Brand Name
Vermed
Version/Model Number
SUN XE-80P
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
dfd82f23-1a21-407d-9e29-11162859bb22
Public Version Date
October 24, 2018
Public Version Number
1
DI Record Publish Date
September 23, 2018
Package DI Number
50009336008181
Quantity per Package
100
Contains DI Package
30009336008187
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 |