Duns Number:118841501
Catalog Number
-
Brand Name
Safety 1st
Version/Model Number
TH091
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)
-
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
bda8026d-0878-403c-b9a2-c829f023da37
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
30884392615810
Quantity per Package
2
Contains DI Package
00884392615819
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 172 |