Duns Number:961027315
Device Description: PENROSE DRAIN 36" X 1"
Catalog Number
30418-100
Brand Name
CARDINAL HEALTH
Version/Model Number
30418-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 27, 2023
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)
Yes
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
-
Product Code
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
c5ce9de3-62b9-4202-b1f7-0660a59155f3
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
October 01, 2018
Package DI Number
50885425505935
Quantity per Package
30
Contains DI Package
10885425505937
Package Discontinue Date
August 27, 2023
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 |