AccessGUDID - DEVICE: SenSura Xpro (05708932687355)

GUDID

Device Identifier (DI) Information

Brand Name: SenSura Xpro
Version or Model: 13639
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13639
Company Name: Coloplast A/S

Primary DI Number: 05708932687355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
64583	One-piece urostomy bag, open-ended	A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXB	COLLECTOR, OSTOMY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
Device Size Text, specify: Base Plate Precut Start Hole Size - in 5/8
Device Size Text, specify: Base Plate Max Cut Size - mm 33
Device Size Text, specify: Base Plate Type Flat
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 16
Device Size Text, specify: Base Plate Max Cut Size - in 1 5/16
Total Volume: 400 Milliliter

Device Record Status

Public Device Record Key: edfca5f4-5a86-4653-97b5-5f99fd625287
Public Version Date: December 13, 2022
Public Version Number: 1
DI Record Publish Date: December 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932687362	5	05708932687355		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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)533-0464
Email: healthcarecs@coloplast.com

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