AccessGUDID - DEVICE: GENTLECATH GLIDE (30768455143550)

GUDID

Device Identifier (DI) Information

Brand Name: GENTLECATH GLIDE
Version or Model: 421568
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 421568
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 30768455143550
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: NEL GENTLECATH TPE CH16X16 IN

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?
34917	Indwelling urethral drainage balloon catheter, non-antimicrobial	A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOD	Catheter, Urological

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
No Device Sizes

Device Record Status

Public Device Record Key: 7f78212e-6bba-482d-a198-a7e6b0a95fe6
Public Version Date: March 31, 2023
Public Version Number: 13
DI Record Publish Date: September 09, 2016