Duns Number:080361159
Device Description: THERMOMETER, RECTAL DIGITAL, ASP RED, 20 SECOND READ
Catalog Number
-
Brand Name
ASP GLOBAL
Version/Model Number
TTASP-RECTAL
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)
-
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
f386a49e-2abb-42bf-8648-d828cc9724b0
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 25, 2019
Package DI Number
20840216107629
Quantity per Package
20
Contains DI Package
10840216107622
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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |