Duns Number:153608369
Device Description: ADMIN SET 92IN 20DP, 2 UNIVERSAL Y
Catalog Number
MS720P
Brand Name
MedStream
Version/Model Number
MS720P
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
K964435,K964435
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
d4f1b319-d48b-44f7-8c86-e72a99e0a941
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10842472100683
Quantity per Package
25
Contains DI Package
00842472100686
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 |