DEVICE: Assura (05708932131124)

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Device Record History
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Device Identifier (DI) Information
Assura
13620
In Commercial Distribution
13620
Coloplast A/S
05708932131124
GS1

1
305524696 *Terms of Use
No description.
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Device Characteristics
MR Safe
No
No
Yes
No
Yes
Yes
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?
48158 Intestinal ostomy base plate, convex
A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate 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. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device.
Active false
31076 Multiple-piece intestinal ostomy bag, open-ended
A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. 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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 655 Milliliter
Device Size Text, specify: Base Plate Type Convex Light
Device Size Text, specify: Coupling Size Diameter - in 2 3/8
Device Size Text, specify: Base Plate Precut Start Hole Size - in 3/8
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 10
Device Size Text, specify: Base Plate Max Cut Size - mm 43
Device Size Text, specify: Base Plate Max Cut Size - in 1 11/16
Lumen/Inner Diameter: 60 Millimeter
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Device Record Status
167f32c0-db8a-4082-b300-c64f52cd3223
December 13, 2022
1
December 05, 2022
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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
05708932131315 5 05708932131124 In Commercial Distribution Retail 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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