DEVICE: HEMODIALYSIS DELIVERY SYSTEM (04987671041517)

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Device Identifier (DI) Information

HEMODIALYSIS DELIVERY SYSTEM
DBB-06

NIKKISO CO.,LTD.
04987671041517
GS1
1
The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients only with acute or chronic renal failure. The DBB-06 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified, trained operator only.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Haemodialysis system dialysate delivery unit An electrically-powered integral unit of a haemodialysis system that prepare and delivers the haemodialysis dialysate solution to the haemodialysis dialyser where it is used in the treatment of the patient (one patient only). It monitors and controls such indicators as temperature, conductivity, flow rate, and pressure.
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FDA Product Code

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Product Code Product Code Name
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
Storage Environment Temperature: between -20 and 60 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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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 29, 2015

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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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None
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Production Identifier(s) in UDI

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Customer Contact

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+81334433727
xxx@xxx.xxx
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