Duns Number:005146311
Device Description: Transfer Set, Two Male Luer Lock Adapters
Catalog Number
1C8189
Brand Name
NA
Version/Model Number
1C8189
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
-
Product Code
NEP
Product Code Name
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Public Device Record Key
b03969ea-b124-43a3-a12d-2bef2fac046f
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50085412020711
Quantity per Package
48
Contains DI Package
00085412020716
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 |