Duns Number:080361159
Device Description: 6” X 9” 1.5MIL, EMPLOYER SOLUTIONS, W/3” FOLD OVER ADHESIVE CLOSURE, BIOHAZARD LOGO, 2.0MI 6” X 9” 1.5MIL, EMPLOYER SOLUTIONS, W/3” FOLD OVER ADHESIVE CLOSURE, BIOHAZARD LOGO, 2.0MIL BACK POUCH, 4C/1S, 3” X 4” DESICCANT PAD, BAR CODED, 100/PK, 10/PKS, 1000/CS
Catalog Number
-
Brand Name
QUEST
Version/Model Number
CVT001
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)
Yes
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
89433a45-5ae8-44e1-bf34-e1729d6f10e0
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |