Duns Number:072943876
Device Description: TOPCARE 2-SECOND FLEX TIP DIGITAL THERMOMETER
Catalog Number
-
Brand Name
TOPCARE
Version/Model Number
52-363
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983887,K983887,K983887
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
46519425-e360-4bae-a53a-dcdb4bbfba18
Public Version Date
August 12, 2020
Public Version Number
1
DI Record Publish Date
August 04, 2020
Package DI Number
20036800451838
Quantity per Package
4
Contains DI Package
00036800451834
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INTERMEDIATE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |