AccessGUDID - DEVICE: Bard® Urodynamic Catheter, Triple Lumen (00801741046506)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Urodynamic Catheter, Triple Lumen
Version or Model: 661435S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 661435S
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741046506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® Urodynamic Catheter, Triple Lumen

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":	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?
62243	Urodynamic manometric catheter, electronic, single-use	A sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may have a lumen to fill/drain the bladder to facilitate pressure measurement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEN	DEVICE, CYSTOMETRIC, HYDRAULIC

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: 7 French

Device Record Status

Public Device Record Key: 885f36d4-7c36-4d4b-863c-550571d2468e
Public Version Date: July 31, 2023
Public Version Number: 3
DI Record Publish Date: August 06, 2016