AccessGUDID - DEVICE: SpeediCath Compact Set (05708932967150)

GUDID

Device Identifier (DI) Information

Brand Name: SpeediCath Compact Set
Version or Model: 28422
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28422
Company Name: Coloplast A/S

Primary DI Number: 05708932967150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. For males only . Length: 11.8 in, Vol 750 ml. Inner catheter CH/FR 12/4.0 mm. Outer catheter CH/FR 18/6.0 mm. Rx only.

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?
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
GBM	CATHETER, URETHRAL

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: This way up. Keep away from sunlight. Do not use if package is damaged and consult IFU.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Catheter Working Length: 11.8 Inch
Device Size Text, specify: Tip Type Straight/Nelaton
Catheter Working Length: 30 Centimeter

Device Record Status

Public Device Record Key: 507aa8fe-19a6-4d16-b4fb-96e3445ddfbf
Public Version Date: January 23, 2025
Public Version Number: 4
DI Record Publish Date: September 02, 2016