Duns Number:126646582
Device Description: A hand-held battery powered, electronic instrument designed to measure a patient's body te A hand-held battery powered, electronic instrument designed to measure a patient's body temperature from the forehead. The device has a rigid tip and a LCD display. It is designed to take a temperature reading. This is a reusable device.
Catalog Number
-
Brand Name
Bestmed
Version/Model Number
HTD8813C
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)
-
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
96f1f6b4-ef6f-4168-9577-1c77b9ea4f73
Public Version Date
May 06, 2020
Public Version Number
1
DI Record Publish Date
April 28, 2020
Package DI Number
40809148200758
Quantity per Package
40
Contains DI Package
00809148200750
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |