Duns Number:134139174
Device Description: PRESSURE MONITORING KIT - STERILE
Catalog Number
PXVP1089
Brand Name
TRUWAVE, VAMP PLUS
Version/Model Number
PXVP1089
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
K142749,K181684,K896819,K142749,K181684,K896819
Product Code
DXO
Product Code Name
TRANSDUCER, PRESSURE, CATHETER TIP
Public Device Record Key
9dd21efd-218d-4e89-9075-384d74641e57
Public Version Date
December 05, 2018
Public Version Number
5
DI Record Publish Date
September 03, 2016
Package DI Number
57460691958420
Quantity per Package
10
Contains DI Package
07460691958425
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 |