Duns Number:005381652
Device Description: PL-1815 Digital Thermometer {Previously Points Of Light NO. THERM} Features an easy-to-r PL-1815 Digital Thermometer {Previously Points Of Light NO. THERM} Features an easy-to-read LCD display, meets FDA requirements and Includes automatic switch-off feature COLOR: BLU
Catalog Number
PL-1815
Brand Name
Digital Thermometer
Version/Model Number
PL-1815
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
3ae1ae20-0ba4-4c42-9d3a-498e02815324
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2016
Package DI Number
10030028000000
Quantity per Package
15
Contains DI Package
00030028000003
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |