DEVICE: Olympus (04953170063800)

Device Identifier (DI) Information

Olympus
MB-156
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170063800
GS1

1
711789789 *Terms of Use
"MB-156 ETO VENTING CAP - FIBERSCOPES"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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 sterilization/disinfection support set A collection of non-powered, non-sterile devices intended to allow connection between the appropriate port(s) of a sterilizer/disinfector and the channels of an endoscope during endoscope sterilization and/or disinfection. It typically includes appropriate tubing, adaptors, connectors to allow the appropriate fluids (sterilant or disinfectant) and gases to flow through the channels of the endoscope, and may include a flow management unit. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
NWB Endoscope, accessories, narrow band spectrum
EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)
EOB NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061313 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b8d19fb4-23c1-44ca-a3e7-2877d60bf213
October 08, 2018
4
September 21, 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

[?]
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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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