Duns Number:007941230
Device Description: Bag Leg With Flip Valve 18 Inch Extension Tubing, Button Hook, 30 Inch Leg Strap Large Cap Bag Leg With Flip Valve 18 Inch Extension Tubing, Button Hook, 30 Inch Leg Strap Large Capacity Bag, Not Made With Natural Rubber Latex Vinyl 32oz (900ml) MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
SLB0032T
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)
-
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
3d7f85cc-591f-4a51-8812-c56fea55c384
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
50885632102125
Quantity per Package
48
Contains DI Package
10885632102127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |