AccessGUDID - DEVICE: e∙Sense (08718122028315)

GUDID

Device Identifier (DI) Information

Brand Name: e∙Sense
Version or Model: Abdominal Catheter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 37040005
Company Name: PendraCare International B.V.

Primary DI Number: 08718122028315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413008652 *Terms of Use

Device Description: e∙Sense Urodynamic catheters are single use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
55837	Urodynamic catheter	A long, thin, sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for urodynamic examination of a patient. It is inserted into the bladder via the urethra or non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output, and for urethral pressure and other urethral and voiding pressure examinations. It is available with various lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a single-use device.	Obsolete	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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: keep away from sunlight
Special Storage Condition, Specify: keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Centimeter
Device Size Text, specify: 7F Diameter

Device Record Status

Public Device Record Key: 205dd7fe-d254-4c04-a1e2-4c15dd7ad15a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 01, 2016