DEVICE: Coloplast (05708932027953)

Device Identifier (DI) Information

Coloplast
01500H
In Commercial Distribution
01500H
Coloplast A/S
05708932027953
GS1

1
305524696 *Terms of Use
Irrigation Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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 kit, reusable A collection of non-sterile devices designed to wash out the colon through a colostomy site. It typically includes a container of fluid, tubing with a cone-shaped tip, or a soft and flexible catheter with a retention shield; it may include some disposables. This is a reusable device after appropriate cleaning.
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FDA Product Code

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Product Code Product Code Name
EXD Irrigator, ostomy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121833 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

e90594d9-62ca-44ab-89b7-06799706c632
July 06, 2018
3
September 22, 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
No Package DIs found
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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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