AccessGUDID - DEVICE: Bardex® Lubricath® Temperature-Sensing Foley Catheter (00801741076954)

GUDID

Device Identifier (DI) Information

Brand Name: Bardex® Lubricath® Temperature-Sensing Foley Catheter
Version or Model: 119418
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 119418
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741076954
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bardex® Lubricath® Temperature-Sensing Foley Catheter

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:	No
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?
46629	Temperature-monitoring indwelling urethral drainage catheter	A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZC	CATHETER, COUDE

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: 18 French
Length: 6 Millimeter

Device Record Status

Public Device Record Key: 1e70cc4c-208a-4c9e-92ab-14b14a9d7504
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 28, 2016