DEVICE: Assura (05708932020206)

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Device Identifier (DI) Information

Assura
12820
12820
Coloplast A/S
05708932020206
GS1
1
Assura Irrigation, Face plate
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Colostomy irrigation ring/belt A non-sterile device intended to secure a colostomy irrigation sleeve to a colostomy site during evacuation of faeces through the stoma. It is a plastic plate/ring with a flange intended to be secured around the stoma and held in place with an included belt. It is intended for use in the home or healthcare facility. This is a single-patient, reusable device.
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FDA Product Code

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Product Code Product Code Name
EXD Irrigator, ostomy
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 14, 2016

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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
05708932645836 5 05708932020206 In Commercial Distribution Retail box
05708932645843 10 05708932645836 In Commercial Distribution Shipper box
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Secondary DI

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

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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
Yes
No
No CLOSE

Customer Contact

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