Duns Number:080361159
Device Description: DIGITAL THERMOMETER, 25 SECOND, ORAL, 20EA/BX, 20BX/CS (400EA/CS)
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
TRA025
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
ae909b4a-cdad-4e2a-bdc0-a0f500dc5cbd
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 09, 2022
Package DI Number
10840216107639
Quantity per Package
10
Contains DI Package
00840216107632
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |