Duns Number:134139174
Device Description: FLOTRAC SENSOR WITH VAMP SYSTEM 60" / 152CM
Catalog Number
MHD6AZ
Brand Name
FLOTRAC, VAMP
Version/Model Number
MHD6AZ
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
Yes
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
K152980,K131588,K131892
Product Code
DQE
Product Code Name
CATHETER, OXIMETER, FIBEROPTIC
Public Device Record Key
1095e908-ccc5-4570-b49b-8d5717fd527f
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 03, 2016
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 |
|---|---|---|
| 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 |