Duns Number:023904428
Device Description: Suction Canister CRITICAL MEASUREMENT / DISPOSABLE Non-Sterile 800ML
Catalog Number
-
Brand Name
Mckesson
Version/Model Number
16-43208-05
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
-
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
2c239018-830d-4322-bdcb-478aad9294c3
Public Version Date
February 04, 2021
Public Version Number
2
DI Record Publish Date
August 03, 2020
Package DI Number
40612479259148
Quantity per Package
4
Contains DI Package
20612479242955
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |