Duns Number:421298453
Device Description: The electronic thermometer consists of temperature sensors, liquid crystal display, button The electronic thermometer consists of temperature sensors, liquid crystal display, button batteries, special integrated circuits and other electronic components. Compared with the traditional mercury glass thermometer, the method has the advantages of convenient reading, short measuring time, high measuring accuracy, memory and buzzing prompt
Catalog Number
-
Brand Name
AGE
Version/Model Number
BT-305
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"
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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
K152508
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
00af7714-f851-47e3-a623-0f465dc28ca4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 29, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |