Duns Number:442126587
Catalog Number
-
Brand Name
MICRO
Version/Model Number
D732 27µ AD ART. FILTER + PURGE LINE
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K952270,K952270
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
530ce1ab-9646-41bb-9c61-393f9fd9dfbe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 03, 2015
Package DI Number
38033178100831
Quantity per Package
6
Contains DI Package
08033178100830
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 398 |
3 | A medical device with high risk that requires premarket approval | 78 |