AccessGUDID - DEVICE: Dover (10884521176508)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: PP16XCSD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PP16XCSD
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521176508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 100% Silicone Silver-Hydrogel Coated Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Adhesive Catheter Securement

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":	No
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32031	Indwelling urethral catheterization kit, adult	A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPG	Urinary Drainage Collection Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 16 French

Device Record Status

Public Device Record Key: 33988901-de79-4697-bae7-fa901d83d1f2
Public Version Date: June 30, 2023
Public Version Number: 7
DI Record Publish Date: September 24, 2016