DEVICE: TERUFLEX TRANSFER BAG (04987350704238)

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Device Record History
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Device Identifier (DI) Information
TERUFLEX TRANSFER BAG
BB*T030CB71
In Commercial Distribution

TERUMO CORPORATION
04987350704238
GS1

1
690543319 *Terms of Use
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

[?]

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?
44904 Blood/tissue storage/culture container
A receptacle 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. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: keep away from sunlight
Special Storage Condition, Specify: Keep away from rain
Special Storage Condition, Specify: Fragile
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 300 Milliliter
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Device Record Status
4bf7f9f8-744b-4da9-8957-9c637aba3d8d
June 17, 2022
3
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54987350704233 4 34987350704239 In Commercial Distribution carton
34987350704239 25 04987350704238 In Commercial Distribution shelfbox
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
3032052510
FDAUDIprogram@terumobct.com
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