AccessGUDID - DEVICE: e•Sense 7Fr Single Sensor Bladder Catheter (00627825013529)

GUDID

Device Identifier (DI) Information

Brand Name: e•Sense 7Fr Single Sensor Bladder Catheter
Version or Model: CATEB27
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Laborie Medical Technologies Corp.

Primary DI Number: 00627825013529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117783313 *Terms of Use

Device Description: e•Sense 7Fr Single Sensor Bladder Catheter

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):	No
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: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: e6502a22-bbfa-43e0-9bee-cfae3cdd5f63
Public Version Date: December 20, 2024
Public Version Number: 1
DI Record Publish Date: December 12, 2024