DEVICE: Qora Arida Stool Management Kit (00860974000327)

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Device Identifier (DI) Information

Qora Arida Stool Management Kit
MG-12014-001

Consure Medical Private Limited
00860974000327
GS1
1
No description.
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Device Characteristics

MR Unsafe
No
Yes
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
Faecal incontinence kit A collection of devices used for the conveyance and collection of liquid/semi-liquid stool (faeces) from the rectum to a collection bag for a patient who is unable to control stool discharge. It typically includes a balloon catheter, a disposable collection bag, a syringe, connectors, and ports for balloon inflation and irrigation. The catheter is inserted into the rectum where it is retained by the inflatable balloon for a prescribed length of time. The kit is appropriate for adult patients in an intensive care unit (ICU), other acute care settings, or for persons with a disability. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KNT Tubes, Gastrointestinal (And Accessories)
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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

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 10, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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