Duns Number:058614483
Device Description: Presternal Peritoneal Dialysis Catheter Kit,Swan Neck, Curl Cath, 1 Cuff,15 Fr/Ch (5.0 mm) Presternal Peritoneal Dialysis Catheter Kit,Swan Neck, Curl Cath, 1 Cuff,15 Fr/Ch (5.0 mm) x 122.3 cm
Catalog Number
8888121132
Brand Name
Argyle
Version/Model Number
8888121132
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
K950042,K950042
Product Code
FJS
Product Code Name
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Public Device Record Key
e5a5540d-5fb2-4ace-91ac-ee0c20eb7f3f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 06, 2015
Package DI Number
20884521196091
Quantity per Package
5
Contains DI Package
10884521196094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |