AccessGUDID - DEVICE: GentleCath Hydrophilic Kit (07333387044156)

GUDID

Device Identifier (DI) Information

Brand Name: GentleCath Hydrophilic Kit
Version or Model: 509012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 509012
Company Name: Wellspect AB

Primary DI Number: 07333387044156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use
Previous DI: 00768455142804

Device Description: Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 14FR

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:	Yes
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?
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWO	Kit, catheter, urinary (exludes HIV testing)
EYY	Drape, urological, disposable
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
EZD	Catheter, straight
LYZ	Vinyl patient examination glove

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
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 16 Inch
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: 25b5a876-9dd7-4e3b-8fb9-33f85894e86f
Public Version Date: November 27, 2024
Public Version Number: 4
DI Record Publish Date: June 01, 2024