Duns Number:492177197
Device Description: NCT-336BLU is a non-contact thermometer allows you to check your baby’s temperature withou NCT-336BLU is a non-contact thermometer allows you to check your baby’s temperature without touching their forehead
Catalog Number
-
Brand Name
iProven
Version/Model Number
NCT-336BLU
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
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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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
6adfbe85-9f41-4b55-abc0-f18cfe6c63d8
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
April 26, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |