Duns Number:134139174
Device Description: FloTrac IQ sensor (five pack)
Catalog Number
MHDQ85
Brand Name
FloTrac IQ
Version/Model Number
MHDQ85
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152980,K152980
Product Code
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
09e2c4af-ef8e-4621-87da-75004e54bc48
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 25, 2018
Package DI Number
50690103197773
Quantity per Package
1
Contains DI Package
00690103197778
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |