Duns Number:121225812
Device Description: Pediatric Tympanic Temperature Probe with 400 Series Thermistor- Sterile
Catalog Number
-
Brand Name
sourcemark
Version/Model Number
SM400TYP
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
765fc206-d98a-4d3b-af56-4993b1ad0a02
Public Version Date
July 09, 2020
Public Version Number
2
DI Record Publish Date
February 19, 2019
Package DI Number
10897392003095
Quantity per Package
50
Contains DI Package
00897392002640
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |