DEVICE: FUJIFILM (04547410332094)
Device Identifier (DI) Information
FUJIFILM
TY-04D
In Commercial Distribution
FUJIFILM CORPORATION
TY-04D
In Commercial Distribution
FUJIFILM CORPORATION
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
40484 | Medical air low pressure hose |
A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilator, anaesthesia unit, anaesthesia system, suctions system, or other medical air dependent device). The gas pressure in the tubing will be low, a "working pressure", having been reduced by a regulator from a higher pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FDA | Enteroscope and accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K143556 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
92931df2-7339-4629-b3cc-9f5665528f45
December 11, 2023
4
September 16, 2016
December 11, 2023
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)272-8465
xxx@xxx.xxx
xxx@xxx.xxx