DEVICE: SenSura Mio Convex (05701780452199)

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Device Record History
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Device Identifier (DI) Information
SenSura Mio Convex
168650
In Commercial Distribution
168650
Coloplast A/S
05701780452199
GS1

10
305524696 *Terms of Use
No description.
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Device Characteristics
MR Safe
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
EXB Collector, ostomy
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: This way up.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 10
Device Size Text, specify: Base Plate Type Convex Deep
Device Size Text, specify: Base Plate Precut Start Hole Size - in 3/8
Device Size Text, specify: Base Plate Max Cut Size - in 7/8
Device Size Text, specify: Base Plate Max Cut Size - mm 23
Device Size Text, specify: Descriptive Bag Size Maxi
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Device Record Status
db488cd7-9da6-4600-9330-bce89c5c81f8
May 08, 2026
1
April 30, 2026
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05701780452205 10 05701780452199 In Commercial Distribution Shipper Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 05701780452212 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
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