AccessGUDID - DEVICE: Porges Coloplast (03600040144183)

GUDID

Device Identifier (DI) Information

Brand Name: Porges Coloplast
Version or Model: AB6318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AB6318
Company Name: Coloplast A/S

Primary DI Number: 03600040144183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: X-FLOW® Prostatectomy catheter Dufour tip 3-way 30-50 ml 100% silicone CH FR 18

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?
32331	Indwelling urethral drainage/irrigation catheter	A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder where it dwells to provide continuous irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional and may have a bent tip (coude) to facilitate negotiation of the prostatic curve in men. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EZL	CATHETER, RETENTION TYPE, BALLOON

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: Store away from light in a cool and dry place

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: c75569f6-9ec6-4046-952b-7b648221d3cb
Public Version Date: October 07, 2024
Public Version Number: 4
DI Record Publish Date: August 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
03600040144190	5	03600040144183		In Commercial Distribution	Retail box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)258-3476
Email: urology@coloplast.com

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