DEVICE: Coloplast (05708932020190)

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Device Identifier (DI) Information

Coloplast
01003
01003
Coloplast A/S
05708932020190
GS1
1
Coloplast Irrigation Sleeves
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 sleeve A non-sterile, soft plastic, open-ended cylinder intended for use during colostomy irrigation to funnel the resultant washout fluid into a sanitary collection receptacle (e.g., a toilet). It is typically attached to a plastic flange placed around the colostomy stoma and held in place by a waist belt. This is a single-use 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
00762123007174 20 00762123001417 In Commercial Distribution Shipper box
00762123001417 10 05708932020190 In Commercial Distribution Retail 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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