Duns Number:042928915
Device Description: 7" Microbore extension set with pinch clamp male luer lock with non-bonded needle-free con 7" Microbore extension set with pinch clamp male luer lock with non-bonded needle-free connector, Purple PINCH clamp High Pressure (Sterile Packaging) BONDED
Catalog Number
-
Brand Name
PME007HPB
Version/Model Number
PME007HPB
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
ccca6529-8922-4e94-ae60-15287ddd8b00
Public Version Date
July 24, 2019
Public Version Number
2
DI Record Publish Date
July 15, 2019
Package DI Number
10850005864438
Quantity per Package
100
Contains DI Package
00850005864431
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. | 45 |