Duns Number:058614483
Device Description: Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuff, Straight,Bent 130
Catalog Number
-
Brand Name
Argyle
Version/Model Number
8888422196
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 30, 2018
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
K890288,K890288
Product Code
FJS
Product Code Name
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Public Device Record Key
333117de-c95c-489f-ac7c-43db372bfb2c
Public Version Date
September 19, 2022
Public Version Number
5
DI Record Publish Date
September 28, 2015
Package DI Number
20884521055817
Quantity per Package
10
Contains DI Package
10884521055810
Package Discontinue Date
March 30, 2018
Package Status
Not 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 |