Duns Number:118841501
Catalog Number
-
Brand Name
Safety 1st
Version/Model Number
IH474
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
K101387,K101387,K101387
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
0f734e47-a035-453e-a78c-a3b0858b8944
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
November 29, 2018
Package DI Number
20884392625027
Quantity per Package
24
Contains DI Package
00884392625023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master
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 |