Duns Number:153608369
Device Description: IV START KIT - CUSTOM
Catalog Number
MSIV-022873
Brand Name
MedStream
Version/Model Number
MSIV-022873
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
a29df61e-4534-4eb0-8377-5f57d401f7c1
Public Version Date
October 06, 2020
Public Version Number
3
DI Record Publish Date
February 13, 2019
Package DI Number
10842472106944
Quantity per Package
50
Contains DI Package
00842472106947
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 202 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |