AccessGUDID - DEVICE: Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter (00801741039911)

GUDID

Device Identifier (DI) Information

Brand Name: Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter
Version or Model: 119316M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 119316M
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741039911
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bardex® Lubri-Sil® I.C. 400 Series Temperature Sensing All-Silicone 5 cc 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):	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:	No
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?
34096	Indwelling urethral drainage balloon catheter, antimicrobial	A flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent 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: 656cd7b4-fe56-45db-bf39-951f83322b73
Public Version Date: December 04, 2020
Public Version Number: 5
DI Record Publish Date: March 04, 2016