Duns Number:961027315
Device Description: Cardinal Health; Foley Catheter Holder Leg Band; Velcro Locking System; Non Adhesive; 2 in Cardinal Health; Foley Catheter Holder Leg Band; Velcro Locking System; Non Adhesive; 2 in. wide; Fits up to 60 in.; Extra Large; Disposable
Catalog Number
FLB60
Brand Name
CARDINAL HEALTH
Version/Model Number
FLB60
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYJ
Product Code Name
HOLDER, URETERAL CATHETER
Public Device Record Key
495a1f26-17ef-4d2e-a74a-44b5f4915f87
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
May 03, 2019
Package DI Number
20885380100311
Quantity per Package
10
Contains DI Package
10885380100314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |