Duns Number:690275362
Catalog Number
-
Brand Name
D'Liv Tip
Version/Model Number
Pumping-25 Tip
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
-
Product Code
GEY
Product Code Name
Motor, Surgical Instrument, Ac-Powered
Public Device Record Key
41df0109-e9fc-483d-8bcc-13a0eca306fe
Public Version Date
April 01, 2022
Public Version Number
2
DI Record Publish Date
January 20, 2022
Package DI Number
18800020100976
Quantity per Package
5
Contains DI Package
08800020100979
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |