Duns Number:080456871
Device Description: Liquid Crystal Temperature Trend Indicator
Catalog Number
1047VS
Brand Name
Vital Signs™
Version/Model Number
1047VS
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
KPD
Product Code Name
STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL
Public Device Record Key
085f8f41-7529-43e0-9d80-bc9afcbcdf60
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
Package DI Number
50190752144482
Quantity per Package
100
Contains DI Package
10190752144484
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |