Duns Number:080342917
Device Description: Dual Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Dual Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
Catalog Number
-
Brand Name
Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System
Version/Model Number
UAC-HM-35P2 3.5 fr. 32cm Polyurethane
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
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
4442485c-d229-485d-a4d0-a6e98d86227e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 19, 2018
Package DI Number
10850584007004
Quantity per Package
5
Contains DI Package
00850584007007
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |