Duns Number:528185295
Device Description: BD Ready-To-Use Hydrophilic Catheter
Catalog Number
RTU10P
Brand Name
BD Intermittent
Version/Model Number
RTU10P
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192468,K192468,K192468
Product Code
EZD
Product Code Name
Catheter, Straight
Public Device Record Key
f3922306-07ac-4bfd-a963-0f2eb2735444
Public Version Date
February 01, 2021
Public Version Number
1
DI Record Publish Date
January 23, 2021
Package DI Number
16948796204039
Quantity per Package
30
Contains DI Package
06948796204032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA