Duns Number:825673239
Device Description: MediChoice® Suction Canister Liner 1000ccDisposableShut-Off Valve10 Each/Bag
Catalog Number
WFM1000LV
Brand Name
MediChoice® Suction Canister Liner
Version/Model Number
1
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
ab0ecc64-039a-4a1b-829f-4cab15a10d25
Public Version Date
October 31, 2019
Public Version Number
1
DI Record Publish Date
October 23, 2019
Package DI Number
40704411005897
Quantity per Package
5
Contains DI Package
20704411005893
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 | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 411 |
U | Unclassified | 1 |