AccessGUDID - DEVICE: GENTLECATH (04026704582402)

GUDID

Device Identifier (DI) Information

Brand Name: GENTLECATH
Version or Model: 421424
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 421424
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 04026704582402
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: CVT GENTLECATH CLOSED RDRUB CH14 KIT

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
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
KOD	Catheter, Urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010420	000

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
Device Size Text, specify: 14 FR

Device Record Status

Public Device Record Key: f10a1894-ede4-4fbf-9e49-f10482cfd2de
Public Version Date: May 23, 2022
Public Version Number: 10
DI Record Publish Date: September 09, 2016