Duns Number:012983893
Device Description: Pediatric Tympanic Temperature Sensor (400 Series Thermistor)
Catalog Number
400-TYP
Brand Name
Starboard Temperature Probes
Version/Model Number
400-TYP
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"
Yes
For Single-Use
Yes
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
K111282,K111282
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
015c483d-e096-4db5-b2a2-02e941fcc0bd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
10850933007105
Quantity per Package
50
Contains DI Package
00850933007108
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |