AccessGUDID - DEVICE: Self-Cath (05708932999915)

GUDID

Device Identifier (DI) Information

Brand Name: Self-Cath
Version or Model: 50196
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50196
Company Name: Coloplast A/S

Primary DI Number: 05708932999915
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Self-Cath®. Urinary Catheter. Straight Tip without connector Female . Catheter Gauge 14 FR/CH, Diameter 4.7 mm.

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":	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?
45603	Single-administration urethral drainage catheter	A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZD	CATHETER, STRAIGHT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100878	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
Outer Diameter: 4.7 Millimeter
Device Size Text, specify: Descriptive Catheter Length Female
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: eae7024f-4cbf-40b3-90ba-5e50ca705e2a
Public Version Date: April 19, 2021
Public Version Number: 1
DI Record Publish Date: April 09, 2021