Duns Number:008124539
Device Description: Needless PRN Pre-Pierced Port Converter
Catalog Number
-
Brand Name
Needless PRN Pre-Pierced Port Converter
Version/Model Number
7056
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"
Yes
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
0e51f54e-be2b-4c6e-8cdd-5afbec8baed2
Public Version Date
September 23, 2021
Public Version Number
1
DI Record Publish Date
September 15, 2021
Package DI Number
00616784705637
Quantity per Package
100
Contains DI Package
00616784705613
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 694 |
2 | A medical device with a moderate to high risk that requires special controls. | 226 |
3 | A medical device with high risk that requires premarket approval | 2 |