Duns Number:300526077
Device Description: Main Unit;
Catalog Number
FHTF3049
Brand Name
TASK FORCE® MONITOR 3040i
Version/Model Number
V2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K014063
Product Code
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
8f52e835-1580-455b-a606-31af0808b182
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
July 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 60 |