Duns Number:488293218
Device Description: Tubing for negative pressure wound therapy powered suction pump
Catalog Number
-
Brand Name
Invia Liberty Y-Connector with quick connector
Version/Model Number
087.0023
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
K142626,K142626,K142626
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
89506d1e-5f5d-4f72-b6e7-7701be38d267
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
07612367049580
Quantity per Package
16
Contains DI Package
07612367049573
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 93 |