AccessGUDID - DEVICE: Denver (10885403076015)

GUDID

Device Identifier (DI) Information

Brand Name: Denver
Version or Model: 42-2005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 42-2005
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403076015
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: Denver Ascites Shunt, 15.5 Fr - Ascites Shunt Single-Valved

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13589	Peritoneovenous shunt	A sterile, surgically implanted, subcutaneous plastic tube used to continuously drain ascites fluid from the peritoneal cavity to the jugular vein. This is a single-use device.	Active	true

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: 15.5 French

Device Record Status

Public Device Record Key: 47887124-ea58-47ab-acd2-65e20b0df1a5
Public Version Date: August 01, 2023
Public Version Number: 4
DI Record Publish Date: June 12, 2017