AccessGUDID - DEVICE: GLOBAL HEALTHCARE (00872237005246)

GUDID

Device Identifier (DI) Information

Brand Name: GLOBAL HEALTHCARE
Version or Model: 60-T01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GHC HEALTHCARE, INC.

Primary DI Number: 00872237005246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884718776 *Terms of Use

Device Description: UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ STERILE WATER, COTTON BALLS (6), VINYL GLOVES (2), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, POVIDONE-IODINE SOLUTION, SPECIMEN CONTAINER 2oz, PATIENT LABEL, FORCEPS, 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):	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:	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?
61355	Urethral catheterization support kit, urinary drainage	A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. 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: 94fec1fc-9045-4e88-ac58-d47b83f260a3
Public Version Date: December 04, 2020
Public Version Number: 5
DI Record Publish Date: February 10, 2017