Duns Number:830767898
Device Description: LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermitt LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation For Use with Flexible Irrigation Container System (previously Hospira product)
Catalog Number
0654401
Brand Name
Irrigation Set
Version/Model Number
654401
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
d90797cd-caf6-4697-a9d9-080f943e088a
Public Version Date
January 23, 2019
Public Version Number
2
DI Record Publish Date
May 31, 2018
Package DI Number
20887787006739
Quantity per Package
20
Contains DI Package
10887787006732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |