Duns Number:005146311
Device Description: One-Link Non-DEHP 3 Lead Microbore Catheter Extension Set Needle-free IV Connector with Ne One-Link Non-DEHP 3 Lead Microbore Catheter Extension Set Needle-free IV Connector with Neutral Fluid Displacement Male Luer Lock Adapter
Catalog Number
7N8332K
Brand Name
ONE-LINK
Version/Model Number
7N8332K
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
K132734,K132734
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
935e8e74-040e-4586-8ab0-9f2b14adc255
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 31, 2017
Package DI Number
50085412599620
Quantity per Package
200
Contains DI Package
00085412599625
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |