Duns Number:153608369
Device Description: ADMIN SET 84IN 1 NF Y-SITE .2M FLOW REG
Catalog Number
MS955E
Brand Name
MedStream
Version/Model Number
MS955E
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
2632e481-e804-423f-821e-4bfd24871c18
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
20842472102745
Quantity per Package
6
Contains DI Package
10842472102748
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 |