DEVICE: Water Container for Model HPU-20 (04953170022784)

Device Identifier (DI) Information

Water Container for Model HPU-20
MAJ-526
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170022784
GS1

1
711789789 *Terms of Use
No description.
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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
Endoscopic irrigation/distension bottle A sterile device intended to be used during endoscopy procedures to provide a receptacle for irrigation water and a conduit for air/carbon dioxide (CO2) used for insufflation. It is typically in the form of a plastic bottle with a connector intended to attach to the proximal end of an endoscope and to gas supplies. It is intended for multi-patient re-use over a 24-hour period before being discarded/replaced.
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FDA Product Code

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Product Code Product Code Name
KNS Unit, electrosurgical, endoscopic (with or without accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K982289 000
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Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Moist Heat or Steam Sterilization
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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

90c04843-226a-4837-9c8e-acd03525698d
July 06, 2018
3
September 21, 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)

[?]
No
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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