AccessGUDID - DEVICE: Self-Cath Closed System (05708932279512)

GUDID

Device Identifier (DI) Information

Brand Name: Self-Cath Closed System
Version or Model: 50277
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50277
Company Name: Coloplast A/S

Primary DI Number: 05708932279512
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Self-Cath Closed System. Soft Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR 14. 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
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070939	000
K223821	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: Do not use if package is damaged and consult IFU.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 14 French
Device Size Text, specify: Tip Type Straight/Nelaton
Catheter Working Length: 12.2 Inch
Catheter Working Length: 31 Centimeter

Device Record Status

Public Device Record Key: b362c4ac-03bf-433c-ac56-b252957092df
Public Version Date: September 08, 2023
Public Version Number: 4
DI Record Publish Date: September 02, 2016