DEVICE: NA (04055207008591)

Device Identifier (DI) Information

NA
163904
In Commercial Distribution
163.904
Richard Wolf GmbH
04055207008591
GS1

1
315304071 *Terms of Use
PRESSURE EQUALIZATION VALVE reusable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
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
FAJ Cystoscope and accessories, flexible/rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K980401 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Hydrogen Peroxide
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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

7fbdd3cd-de34-4471-996b-45a86aa654c6
July 06, 2018
3
September 29, 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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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