Duns Number:401738638
Device Description: Suction bag, 1000 ml for Serres Suction bag system
Catalog Number
-
Brand Name
Suction bag, 1000 ml
Version/Model Number
570157
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
343fe199-7c62-479f-ab23-b8211aaa9d51
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 05, 2018
Package DI Number
06418685047328
Quantity per Package
6
Contains DI Package
06418685047311
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Delivery
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |