Duns Number:421356348
Device Description: Model: PC868;Brand: FLTR;One inner packing box contains 4 devices;One outer packing box co Model: PC868;Brand: FLTR;One inner packing box contains 4 devices;One outer packing box contains 5 inner packing boxes.
Catalog Number
-
Brand Name
FLTR
Version/Model Number
PC868
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172889,K172889,K172889
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
356a5480-6069-44b7-a71e-6603f6fd0762
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
July 17, 2020
Package DI Number
10840061486828
Quantity per Package
4
Contains DI Package
00840061486821
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Packing Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |