AccessGUDID - DEVICE: Denver (10885403076008)

GUDID

Device Identifier (DI) Information

Brand Name: Denver
Version or Model: 42-2055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42-2055
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403076008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: DENVER™ ASCITES SHUNT PERCUTANEOUS ACCESS KIT SINGLE VALVE

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 374257b1-cdf4-4379-a886-79959d4de95d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 12, 2017