AccessGUDID - DEVICE: Bardex® I.C Complete Care® Temp-Sensing Foley Catheter with Urine Meter (00801741147487)

GUDID

Device Identifier (DI) Information

Brand Name: Bardex® I.C Complete Care® Temp-Sensing Foley Catheter with Urine Meter
Version or Model: MT319416AM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT319416AM
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741147487
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bardex I.C. Complete Care Infection Control Temperature Sensing Foley Catheter Tray with StatLock Stabilization Device and 350ml Urine Meter.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
MJC	Catheter, urological (antimicrobial) and accessories

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
Catheter Gauge: 16 French

Device Record Status

Public Device Record Key: de8c75a1-ce46-41bb-8549-20089572872d
Public Version Date: December 04, 2020
Public Version Number: 2
DI Record Publish Date: August 06, 2020