Duns Number:961027315
Device Description: Standard Leg Bag 900ml; Pre-connected 18 in. Entension Tube; Twist valve; Fabric Leg Strap Standard Leg Bag 900ml; Pre-connected 18 in. Entension Tube; Twist valve; Fabric Leg Straps; Sterile Fluid Pathways
Catalog Number
LB900T
Brand Name
CARDINAL HEALTH
Version/Model Number
LB900T
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
FAQ
Product Code Name
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
Public Device Record Key
df5e1bb2-78a7-4518-a9d8-1f0c38977234
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
July 19, 2019
Package DI Number
50885380126381
Quantity per Package
24
Contains DI Package
10885380126383
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 |