DEVICE: Denver (10885403076008)
Device Identifier (DI) Information
Denver
42-2055
In Commercial Distribution
42-2055
CAREFUSION 2200, INC
42-2055
In Commercial Distribution
42-2055
CAREFUSION 2200, INC
DENVER™ ASCITES SHUNT PERCUTANEOUS ACCESS KIT SINGLE VALVE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Pleural/peritoneal drainage catheterization kit | A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPM | Shunt, Peritoneal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Number of Valves: 1 |
Catheter Gauge: 11.5 French |
Device Record Status
374257b1-cdf4-4379-a886-79959d4de95d
March 29, 2018
2
June 12, 2017
March 29, 2018
2
June 12, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50885403076006 | 5 | 10885403076008 | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined