Duns Number:112164780
Device Description: Extension Tubing with Connector; 18 in.
Catalog Number
LB18ET
Brand Name
CARDINAL HEALTH
Version/Model Number
LB18ET
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
BYY
Product Code Name
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
Public Device Record Key
8b27fb7d-f37a-4864-9c04-f91386f6f9c4
Public Version Date
July 29, 2019
Public Version Number
1
DI Record Publish Date
July 19, 2019
Package DI Number
50885380126411
Quantity per Package
50
Contains DI Package
10885380126413
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 |