DEVICE: FUJIFILM (04547410332063)

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Device Identifier (DI) Information

FUJIFILM
PB-30

FUJIFILM CORPORATION
04547410332063
GS1
1
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
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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
Catheter-balloon inflator, reusable A device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. It typically consists of a dedicated syringe/plunger, a gauge for monitoring pressure [e.g., in atmosphere(s) (atm) or pounds per square inch (psi)], a locking mechanism, and a connecting tube. It may also be used to inflate the balloon of an inflatable balloon tamp or an endomicroscopy probe. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FDA Enteroscope and accessories
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Sterilization

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

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Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
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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 16, 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
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Yes
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Customer Contact

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+1(800)272-8465
xxx@xxx.xxx
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