Duns Number:005146311
Device Description: Y-Type Blood/Solution Set, 40 and 150 Micron Dual Screen Filter, Injection Site, Male Luer Y-Type Blood/Solution Set, 40 and 150 Micron Dual Screen Filter, Injection Site, Male Luer Lock Adapter with Retractable Collar
Catalog Number
4C6838
Brand Name
INTERLINK
Version/Model Number
4C6838
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K932301,K932301
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
9eb5f401-d1bd-4440-be4e-9bd21a6d4de2
Public Version Date
November 19, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
50085412031199
Quantity per Package
48
Contains DI Package
00085412031194
Package Discontinue Date
June 30, 2020
Package Status
Not 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |