DEVICE: FloSure (04260160094295)

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Device Identifier (DI) Information

FloSure
FloSure Ventilation Patch
100520
SIMEX Medizintechnik GmbH
04260160094295
GS1
1
simex FloSure Ventilation Patch for the vacuum wound drainage
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Synthetic polymer semi-permeable film dressing, adhesive, sterile A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
OMP Negative Pressure Wound Therapy Powered Suction Pump
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Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 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 24, 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
14260160094292 20 04260160094295 In Commercial Distribution white paperboard box
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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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+49742092040
info@simexmed.de
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