AccessGUDID - DEVICE: Dover (30884521015894)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 8887649229
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8887649229
Company Name: Cardinal Health, Inc.

Primary DI Number: 30884521015894
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Silicone Elastomer Coated Latex Foley Catheter,Nylon Spiral Reinforced Catheter Wall, 30-50 mL, 3-Way

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
34930	Single-administration urethral drainage/irrigation catheter	A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOD	CATHETER, UROLOGICAL

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
Special Storage Condition, Specify: Keep Dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sire Type - Total Volume, 30-50 ML;

Device Record Status

Public Device Record Key: d6021917-83d9-4d76-9ebd-c12f3517661b
Public Version Date: October 28, 2019
Public Version Number: 7
DI Record Publish Date: September 24, 2016