Duns Number:153608369
Device Description: ULTRA MB 60IN EXT SET LL,SLD CLMP,APV.38
Catalog Number
MS407
Brand Name
MedStream
Version/Model Number
MS407
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
0cc8996e-5bac-4ae7-9335-ca11baed5535
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10842472100508
Quantity per Package
50
Contains DI Package
00842472100501
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 |