Duns Number:134139174
Device Description: PRESSURE MONITORING SET
Catalog Number
PXCMK315
Brand Name
TruWave
Version/Model Number
PXCMK315
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
K171996,K171996
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
1fa538a7-106e-43d5-b2e2-81dba1658d58
Public Version Date
August 23, 2018
Public Version Number
1
DI Record Publish Date
July 23, 2018
Package DI Number
50690103011543
Quantity per Package
20
Contains DI Package
00690103011548
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 |