Duns Number:184763290
Catalog Number
MISER1/B
Brand Name
Miser™
Version/Model Number
00884450116982
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
10f05a94-8c86-4a1a-bd96-9a042109b908
Public Version Date
November 01, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884450116989
Quantity per Package
10
Contains DI Package
00884450116982
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 | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |