AccessGUDID - DEVICE: SenSura Mio Flex; Assura AC (05708932131186)

GUDID

Device Identifier (DI) Information

Brand Name: SenSura Mio Flex; Assura AC
Version or Model: 13627
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 13627
Company Name: Coloplast A/S

Primary DI Number: 05708932131186
Issuing Agency: GS1
Commercial Distribution End Date: July 10, 2024
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?
48159	Intestinal ostomy base plate, flat	A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. This is a single-use device.	Active	false
31069	Multiple-piece urostomy bag, open-ended	A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/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 3/8
Device Size Text, specify: Base Plate Type Flat
Lumen/Inner Diameter: 50 Millimeter
Device Size Text, specify: Base Plate Max Cut Size - mm 48
Device Size Text, specify: Base Plate Max Cut Size - in 1 7/8
Total Volume: 475 Milliliter
Device Size Text, specify: Coupling Size Diameter - in 1 15/16
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 10

Device Record Status

Public Device Record Key: 2549b44c-6683-4cc3-889c-cefbf7b79704
Public Version Date: July 12, 2024
Public Version Number: 2
DI Record Publish Date: December 05, 2022