AccessGUDID - DEVICE: Dover (10885380176739)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: P4P18CSDK2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P4P18CSDK2
Company Name: Cardinal Health, Inc.

Primary DI Number: 10885380176739
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 100 percent Silicone Urine Meter Foley Tray with coude tip

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:	Yes
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
FCN	Urinary drainage collection kit, for indwelling catheter

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 545a5e00-43a8-44aa-a1ba-a190a1cadc29
Public Version Date: September 04, 2024
Public Version Number: 5
DI Record Publish Date: March 17, 2021