Duns Number:025460908
Device Description: NICU EXT LINE 55' TRIFUSE SMBORE W/LBLS
Catalog Number
DYNDA2477
Brand Name
MEDLINE
Version/Model Number
DYNDA2477
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
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
83880552-1ba6-4057-8b77-639bdb3269ae
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 15, 2020
Package DI Number
20193489191681
Quantity per Package
50
Contains DI Package
10193489191684
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |