Duns Number:112164780
Device Description: THORA PARA CATH DRN 8FR x 5IN
Catalog Number
30-CE8CA
Brand Name
CARDINAL HEALTH
Version/Model Number
30-CE8CA
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
GCX
Product Code Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Public Device Record Key
75e16245-8871-4585-91be-96ac0ff742bd
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
March 14, 2017
Package DI Number
50887488646723
Quantity per Package
10
Contains DI Package
10887488646725
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 | 81 |
2 | A medical device with a moderate to high risk that requires special controls. | 111 |