Duns Number:005146311
Device Description: The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supp The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.
Catalog Number
MSGDHC1325A
Brand Name
GAMCATH TRAY
Version/Model Number
GAMHRVA05A
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PEV
Product Code Name
Dialysis administration kits (convenience kit)
Public Device Record Key
beac6fe3-433e-4772-9396-052e65c0c5ee
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
November 10, 2015
Package DI Number
55413765500294
Quantity per Package
5
Contains DI Package
05413765500299
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |