DEVICE: MIZUHO OSI (D806OSI5844112)

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Device Identifier (DI) Information

MIZUHO OSI
OSI5844-11

MAYTEX CORPORATION
D806OSI5844112
HIBCC
240
OSI Pad cover
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Bedding set A collection of bedding materials including a bed sheet, pillow cover, and a duvet cover all typically made of a thin non-woven or textile laminate intended to create a physical barrier to soiling and cross-contamination. This set is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).
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FDA Product Code

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Product Code Product Code Name
MMP Cover, Barrier, Protective
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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: D806OSI5844110 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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