Duns Number:044611812
Device Description: Groshong CV Catheter Repair Kit for Use with Groshong 7F Single-Lumen CV Catheter
Catalog Number
7741700
Brand Name
Groshong CV Catheter Repair Kit
Version/Model Number
7741700
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
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
960abe1b-94ed-452b-af49-121b05e16ab8
Public Version Date
March 12, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
10801741037723
Quantity per Package
5
Contains DI Package
00801741037726
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
U | Unclassified | 8 |