DEVICE: TERUFLEX TRANSFER BAG (04987350704450)

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Device Identifier (DI) Information

TERUFLEX TRANSFER BAG
BB*T080BB71

TERUMO CORPORATION
04987350704450
GS1
1
TERUFLEX TRANSFER BAG
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Blood/tissue storage/culture container A durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
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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 15 and 30 Degrees Celsius
Special Storage Condition, Specify: keep away from sunlight
Special Storage Condition, Specify: Keep away from rain
Special Storage Condition, Specify: Fragile
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Clinically Relevant Size

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Size Type Text
Total Volume: 800 Milliliter
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Device Status

In Commercial Distribution
August 12, 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
54987350704455 4 34987350704451 In Commercial Distribution carton
34987350704451 25 04987350704450 In Commercial Distribution shelfbox
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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(303)-205-2510
FDAUDIprogram@terumobct.com
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