DEVICE: Colonic irrigation Kit (B482Z100)
Device Identifier (DI) Information
Colonic irrigation Kit
Small Hydrokit
In Commercial Distribution
Z-10
TRANSCENDENCIAS COMERCIALES SL
Small Hydrokit
In Commercial Distribution
Z-10
TRANSCENDENCIAS COMERCIALES SL
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a small size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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60903 | Colonic lavage kit, non-surgical |
A collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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KPL | Colonic Irrigation System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K131852 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Avoid sunlight |
Storage Environment Temperature: less than 35 Degrees Celsius |
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
437c99bc-c64a-4db4-8aee-560e6ffa700e
November 24, 2022
7
December 29, 2016
November 24, 2022
7
December 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B482Z101 | 75 | B482Z100 | In Commercial Distribution | Box | |
B482Z102 | 100 | B482Z100 | 2222-11-04 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined