Duns Number:240623124
Device Description: The Catheter Repair Clamp is designed with additional openings along the side and the top The Catheter Repair Clamp is designed with additional openings along the side and the top of the clamp to be quickly added or removed from tubing.
Catalog Number
CM-604
Brand Name
rescuCLAMP™ Catheter Repair Clamp
Version/Model Number
1.5
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
FKK
Product Code Name
Clamp, Line
Public Device Record Key
0677ff50-29f4-4e8f-ba56-a0309990794b
Public Version Date
April 29, 2021
Public Version Number
1
DI Record Publish Date
April 21, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 34 |