Duns Number:421356348
Device Description: Model: PC828;Brand: FLTR;One inner packing tray contains 6 devices;One outer packing box c Model: PC828;Brand: FLTR;One inner packing tray contains 6 devices;One outer packing box contains 36 inner packing trays.
Catalog Number
-
Brand Name
FLTR
Version/Model Number
PC828
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
78e17f6b-d17b-498f-a127-935909e9902a
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
August 17, 2020
Package DI Number
10840061482820
Quantity per Package
6
Contains DI Package
00840061482823
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Packing Tray
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |