Duns Number:134139174
Device Description: PRESSURE MONITORING ACCESSORY
Catalog Number
MFNVC
Brand Name
TRUWAVE
Version/Model Number
MFNVC
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
K142749,K171996,K142749,K171996
Product Code
DXO
Product Code Name
TRANSDUCER, PRESSURE, CATHETER TIP
Public Device Record Key
bfca758b-7dda-4b88-93ed-cd000b0bc06e
Public Version Date
August 07, 2020
Public Version Number
6
DI Record Publish Date
September 03, 2016
Package DI Number
57460691959625
Quantity per Package
50
Contains DI Package
07460691959620
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 |