Duns Number:126830020
Device Description: LS7020 2000cc Suction Canister
Catalog Number
LS7020
Brand Name
MD Resource
Version/Model Number
LS7020
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
K854359,K854359
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
9f334ddc-bb51-452e-a5e7-7c9931ac6c0b
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
October 31, 2016
Package DI Number
10859898006383
Quantity per Package
10
Contains DI Package
00859898006386
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |