AccessGUDID - DEVICE: Dover (10884521003460)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 8884733900
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8884733900
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521003460
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Urine Leg Bag with Extension Tube

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:	No
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?
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	COLLECTOR, URINE, (AND ACCESSORIES) 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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Length: 18 Inch

Device Record Status

Public Device Record Key: e30a6d9b-1c52-4018-a066-70e6736681e4
Public Version Date: September 02, 2024
Public Version Number: 9
DI Record Publish Date: September 24, 2016