Duns Number:547055364
Catalog Number
-
Brand Name
Disposable Hemodialysis Access Catheter Set Double Lumen12F*20cm(Straight)
Version/Model Number
G2Z-FR-2216
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MPB
Product Code Name
Catheter, Hemodialysis, Non-Implanted
Public Device Record Key
5327b1a8-674d-4bde-896b-760264126f59
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
26938634491742
Quantity per Package
40
Contains DI Package
16938634491745
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. | 167 |