Duns Number:134139174
Device Description: PRESSURE MONITORING SET
Catalog Number
T310845A
Brand Name
TruWave, VAMP
Version/Model Number
T310845A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
5f741229-b746-41f6-9156-b13532fd8096
Public Version Date
August 31, 2020
Public Version Number
1
DI Record Publish Date
August 21, 2020
Package DI Number
57460691959977
Quantity per Package
20
Contains DI Package
07460691959972
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 |