Duns Number:421356348
Device Description: Model: PC801;Brand: FLTR;One inner packing box contains 4 device;One outer packing box con Model: PC801;Brand: FLTR;One inner packing box contains 4 device;One outer packing box contains 5 inner packing boxes.Per outer packing box can pack 20 devices.
Catalog Number
-
Brand Name
FLTR
Version/Model Number
PC801
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
K190717,K190717,K190717
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
01ad18c9-5f12-43b4-9da5-28a85c78bdd5
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 26, 2020
Package DI Number
10840061480116
Quantity per Package
4
Contains DI Package
00840061480119
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 |