AccessGUDID - DEVICE: Dover (10884521176683)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 20516ICC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20516ICC
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521176683
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 100% Silicone Silver-Hydrogel Coated Foley Catheter,Coude Tip, 5 mL, 2-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):	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:	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?
34096	Indwelling urethral drainage balloon catheter, antimicrobial	A flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent 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
EZL	CATHETER, RETENTION TYPE, BALLOON

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
Catheter Gauge: 16 French
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: c73eb84f-536e-40b1-8b73-b731225bceb3
Public Version Date: October 18, 2024
Public Version Number: 11
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521176680	10	10884521176683	2025-12-31	In Commercial Distribution	PACK_OR_INNER_PACK
30884521176687	100	10884521176683	2025-12-31	In Commercial Distribution	CASE