Duns Number:961027315
Device Description: RM Suction Canister Kit, 800cc W/Floater Top
Catalog Number
ZRSUCC48K
Brand Name
CARDINAL HEALTH
Version/Model Number
ZRSUCC45K
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)
-
Over the Counter (OTC)
Yes
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
1c8882f2-e9b6-49c2-8b97-bb670ac53657
Public Version Date
July 20, 2018
Public Version Number
3
DI Record Publish Date
August 12, 2016
Package DI Number
50885380110595
Quantity per Package
48
Contains DI Package
00885380110590
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |