AccessGUDID - DEVICE: Biotronix Healthcare Foley Trays (00850005165002)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronix Healthcare Foley Trays
Version or Model: UR1428FT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Primary DI Number: 00850005165002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065762392 *Terms of Use

Device Description: Pre-Connected Latex Foley Tray 18FR

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
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
OHR	Catheter Care Tray

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Pre-Connected Latex Foley Tray 18FR

Device Record Status

Public Device Record Key: e15d17a9-5abe-462d-8859-c9eae1403f14
Public Version Date: December 04, 2020
Public Version Number: 3
DI Record Publish Date: October 04, 2019