DEVICE: FUJIFILM (04547410332094)

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Device Identifier (DI) Information

FUJIFILM
TY-04D

FUJIFILM CORPORATION
04547410332094
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
No
No
No
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No
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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
Medical air low pressure tubing A length of flexible tube intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilators, anaesthesia units, anaesthesia systems, suctions systems and other medical air dependent devices). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is intended for use within a static clinical environment (e.g., intensive care), is colour-coded for medical air, and reinforced (e.g., with woven polyester or cotton). It is available in various lengths, including standard coil lengths. 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
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
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: There must be no condensation.
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
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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
No
Yes
No
No CLOSE

Customer Contact

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