AccessGUDID - DEVICE: SpeediCath Flex Coude Pro (05708932125307)

GUDID

Device Identifier (DI) Information

Brand Name: SpeediCath Flex Coude Pro
Version or Model: 20010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20010
Company Name: Coloplast A/S

Primary DI Number: 05708932125307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization.

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
GBM	CATHETER, URETHRAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190620	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
Special Storage Condition, Specify: Keep away from sunlight. Do not use if package is damaged and consult IFU.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 10 French
Device Size Text, specify: Tip Type Flex Coudé
Catheter Working Length: 33 Centimeter
Catheter Working Length: 13 Inch

Device Record Status

Public Device Record Key: dc18cb34-544d-4584-9db5-ec013af5c67b
Public Version Date: November 13, 2023
Public Version Number: 2
DI Record Publish Date: July 12, 2019