Duns Number:544474402
Device Description: Non Contact Infrared Body Thermometer
Catalog Number
-
Brand Name
Sweet Dreamers
Version/Model Number
HTD8813C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 13, 2020
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c7c28871-87c6-4f79-bb38-2fd3de617f0d
Public Version Date
April 28, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2020
Package DI Number
15060216820566
Quantity per Package
40
Contains DI Package
05060216820569
Package Discontinue Date
July 13, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |