DEVICE: n.a. (04048551054871)

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Device Identifier (DI) Information

n.a.
13242LX

Karl Storz GmbH & Co. KG
04048551054871
GS1
1
Leakage Tester
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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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
Endoscope leak tester, mechanical A hand-operated device used to test a flexible endoscope for leaks from its internal channels. It is connected to the endoscope using tubing with connectors to subject the channels to a build-up of air pressure that is created with a hand pump (a bulb). Its manometer will display the pressure and leakage is indicated by a fall in pressure observed on the manometer gauge. It is typically used by healthcare personnel who use endoscopes to validate the patency of the endoscope prior to clinical use, or to substantiate suspicion of a leakage. This process is used as a first line test for early detection of pinhole leaks to minimize inadvertent incidences with the patient.
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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
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 Status

In Commercial Distribution
September 23, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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