Duns Number:080378236
Device Description: Digital Thermometer enables fast and reliable measurements. These thermometers provide ver
Catalog Number
DT-F10S-4333
Brand Name
OCCObaby
Version/Model Number
OCCOflex 43
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
61cf49f8-812b-4185-8879-14cc7c1e61b5
Public Version Date
June 23, 2022
Public Version Number
4
DI Record Publish Date
October 21, 2020
Package DI Number
10850016971101
Quantity per Package
10
Contains DI Package
00850016971104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |