Duns Number:401738638
Catalog Number
-
Brand Name
Suction bag with dual filter, 2000ml
Version/Model Number
570167-5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2020
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
b92799ca-1adf-48f9-9db4-93cba5f9f5d7
Public Version Date
August 17, 2020
Public Version Number
3
DI Record Publish Date
February 05, 2018
Package DI Number
06418685061959
Quantity per Package
6
Contains DI Package
06418685061942
Package Discontinue Date
January 20, 2020
Package Status
Not in Commercial Distribution
Package Type
Delivery box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |