Duns Number:105932508
Device Description: School Health Digital Thermometer, 30 second, Flexible Tip
Catalog Number
-
Brand Name
School Health
Version/Model Number
40-030-240-SH-L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
95f4b774-d3cf-42ac-a5b6-0c71699ad5ac
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 24, 2016
Package DI Number
00845821028341
Quantity per Package
12
Contains DI Package
00845821027498
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |