AccessGUDID - DEVICE: Dover (10884521051614)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 8884731998
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8884731998
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521051614
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: Urinary Extension Tubing with Connector

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
64085	Non-ISO80369-standardized small-bore linear connector, reusable	A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with a connection at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a reusable 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: No
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
Length: 18 Inch

Device Record Status

Public Device Record Key: 26c8027f-d9ec-4984-be07-a97d73fdf978
Public Version Date: September 02, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016