Duns Number:005146311
Device Description: Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Colla Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
Catalog Number
2R1146
Brand Name
NA
Version/Model Number
2R1146
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
K172544,K172544
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
55ede469-a54e-47f9-9cd0-210028920a34
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
March 29, 2019
Package DI Number
50085412565946
Quantity per Package
48
Contains DI Package
00085412565941
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 |