DEVICE: PRISMAFLEX TPE 2000 SET (07332414111038)

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Device Identifier (DI) Information

PRISMAFLEX TPE 2000 SET
114093
114093
GAMBRO INDUSTRIES
07332414111038
GS1
1
The PRISMAFLEX TPE2000 Set is a disposable, extracorporeal circuit for use with the PRISMAFLEX System having selected ‘TPE’ therapy. The PRISMAFLEX TPE2000 Set is indicated for use only with the PRISMAFLEX Control Unit, after having selected TPE therapy (therapeutic plasma exchange).The PRISMAFLEX TPE2000 Set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
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
Apheresis system filter, whole blood A sterile device designed to separate plasma from the cellular components of whole blood during manual/automated apheresis (the separation, collection, and reinfusion of blood) for donation of blood products or apheresis therapy. It typically contains a microporous membrane (usually with pores 0.2 to 0.6 micrometers) or a hollow-fibre column; it may also be intended to filter microorganisms and/or particles. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 0 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
March 23, 2017

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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
37332414111039 4 07332414111038 In Commercial Distribution CASE
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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)933-0303
Medinfo_medproducts@baxter.com
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