Duns Number:017246562
Device Description: IV START KIT
Catalog Number
DYNDV2273
Brand Name
MEDLINE
Version/Model Number
DYNDV2273
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRS
Product Code Name
I.V. start kit
Public Device Record Key
1ecd762a-5442-4279-bb59-e92e2b011f87
Public Version Date
April 21, 2020
Public Version Number
1
DI Record Publish Date
April 13, 2020
Package DI Number
20888277732732
Quantity per Package
50
Contains DI Package
10888277732735
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |