DEVICE: 3ME-SC203A TSCDII 110V (05020583300033)

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Device Identifier (DI) Information

3ME-SC203A TSCDII 110V
3MESC203A

TERUMO BCT, INC.
05020583300033
GS1
1
3Me-Sc203A TSCDII 110V
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Package sealing unit A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories.
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FDA Product Code

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Product Code Product Code Name
KSB SET, TRANSFER (BLOOD/PLASMA)
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Protect from rain
Storage Environment Temperature: between 2 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep out of sunlight.
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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 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
No Package DIs found
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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)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(303)205-2510
FDAUDIprogram@terumobct.com
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