DEVICE: E-LINE (04055207029015)

Device Identifier (DI) Information

E-LINE
89700261
In Commercial Distribution
8970.0261
Richard Wolf GmbH
04055207029015
GS1

1
315304071 *Terms of Use
ADAPTER FOR MORCESCOPE compatible with connection part 86543842, reusable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Endoscope assembly adaptor A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FJK SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041610 000
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Sterilization

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

94ec48ff-4c11-488d-9a17-c95254d776ed
July 06, 2018
3
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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+497043350
info@richard-wolf.com
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