Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
303000W
Brand Name
Genius 2
Version/Model Number
303000W
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 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"
-
For Single-Use
-
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
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
683ffdd7-5734-4a2c-b8e6-e3c6e226f0ed
Public Version Date
April 29, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521138220
Quantity per Package
12
Contains DI Package
10884521138223
Package Discontinue Date
February 28, 2019
Package Status
Not 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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |