AccessGUDID - DEVICE: Dover (10884521030466)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 8887660242
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8887660242
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521030466
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Red Rubber Urethral Catheter

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?
46626	Intermittent urethral drainage catheter, antimicrobial	A flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal; it is also coated with an antibiotic or antimicrobial agent to help prevent infection of the urinary tract. This is a reusable device on the same patient for a limited period of time.	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: ;

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 24 French

Device Record Status

Public Device Record Key: 4b52ff83-7317-47cf-8fa9-89296e26f9ef
Public Version Date: December 17, 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
30884521030460	1500	10884521030466	2024-12-15	Not in Commercial Distribution	PALLET
20884521030463	100	10884521030466	2024-12-15	Not in Commercial Distribution	CASE