Duns Number:695407034
Device Description: This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a M This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifold part and a Shaft parts. The Manifold Parts is equipped with a non-return valve for inflate the balloon and a band to fix the non-return valve and to identify the catheter’s size by color. The Shaft parts has an x-ray opaque line for check to position and balloon for located the catheter in the bladder, a drainage eye for urine drainage, and a rounded tip for easy insertion of the shaft. The proposed device is supplied in French size ranging from 12 to 24. It is available in 337(±15) and 345(±15) mm length with various balloon sizes. The devices are applied for adults only.
Catalog Number
-
Brand Name
2Way Foley Balloon Catheter
Version/Model Number
APO-FC-012
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"
-
For Single-Use
Yes
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
K201776,K201776,K201776
Product Code
EZL
Product Code Name
Catheter, Retention Type, Balloon
Public Device Record Key
379c31c5-86f4-4d9d-a615-397136ebe8d0
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
Package DI Number
18800109201525
Quantity per Package
10
Contains DI Package
08800109201528
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-