AccessGUDID - DEVICE: Medline (10080196117512)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: DYK1101835FL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DYK1101835FL
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10080196117512
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

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
PPB	Foley catheter kit (excludes HIV testing)

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: No
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: 2ab2f47a-a5de-4205-88da-62309aa0dc25
Public Version Date: March 08, 2022
Public Version Number: 4
DI Record Publish Date: October 14, 2016