AccessGUDID - DEVICE: GLOBAL HEALTHCARE (00872237008162)

GUDID

Device Identifier (DI) Information

Brand Name: GLOBAL HEALTHCARE
Version or Model: 60-T1652
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GHC HEALTHCARE, INC.

Primary DI Number: 00872237008162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884718776 *Terms of Use

Device Description: PRE-CONNECTED FOLEY CATHETER TRAY. CONTENTS: SILICONE COATED LATEX FOLEY CATHETER 16FR, 5CC. DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ STERILE WATER, VINYL GLOVES (2), PVP SWABSTICKS (3), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, PATIENT LABEL, WRAP.

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:	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
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31d8e04d-f7c8-4e6e-99b4-5246f0d052dd
Public Version Date: December 04, 2020
Public Version Number: 4
DI Record Publish Date: February 10, 2017