Duns Number:005083209
Device Description: CLEARLINK System. Non-DEHP Solution Set with DUO-VENT Spike
Catalog Number
2R8403
Brand Name
CLEARLINK
Version/Model Number
2R8403
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112893,K112893
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
6972ccc6-9e9e-47c0-b43e-3e4bee3d0473
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
May 31, 2019
Package DI Number
50085412656644
Quantity per Package
48
Contains DI Package
00085412656649
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 |