Duns Number:005083209
Device Description: The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilitate perito The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilitate peritoneal dialysis set connector insertion into and removal from, Peritoneal Dialysis Solution in plastic container.
Catalog Number
5C4527
Brand Name
NA
Version/Model Number
5C4527
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
69540e44-a99f-4488-9a49-15f26a1f0f57
Public Version Date
November 18, 2020
Public Version Number
3
DI Record Publish Date
March 15, 2019
Package DI Number
50085412025365
Quantity per Package
12
Contains DI Package
00085412025360
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |