DEVICE: Pure-Vu (05060513700045)

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Device Identifier (DI) Information

Pure-Vu
PV-OSK-001
PV-OSK-001
MOTUS GI MEDICAL TECHNOLOGIES LTD
05060513700045
GS1
1
(1) Oversleeve
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Colonic lavage system, powered-flow A device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris from the colon. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated fluids (e.g., saline), an extractor (frequently using vacuum), and controls for the temperature and the rate of infusion (e.g., using a nozzle) and withdrawal of the liquid; the system is coupled to dedicated handpieces and/or to disposable catheters introduced through the rectum. It is intended to be used by a healthcare provider in a clinical setting to remove damaged tissue and/or debris (e.g., faeces, foreign objects).
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FDA Product Code

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Product Code Product Code Name
FDF Colonoscope And Accessories, Flexible/Rigid
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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
Handling Environment Atmospheric Pressure: between 0 and 81 KiloPascal
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
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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
January 03, 2017

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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
05060513700090 5 05060513700045 In Commercial Distribution Large 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
888-438-9996
customer@motusgi.com
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