DEVICE: TSCD (04987350726971)

Device Identifier (DI) Information

TSCD
SC*W017
In Commercial Distribution

TERUMO CORPORATION
04987350726971
GS1

70
690543319 *Terms of Use
TSCD Wafers
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
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

[?]
Product Code Product Code Name
KSB SET, TRANSFER (BLOOD/PLASMA)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: non-condensing, This way up, Fragile, handle with care, Stacking limit by 10, Keep away from sunlight, Keep dry
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

984d3f34-0fb1-4bd5-b897-0f6b39e47dcd
March 29, 2018
2
September 09, 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
34987350726972 2 04987350726971 In Commercial Distribution
54987350726976 40 04987350726971 In Commercial Distribution
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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

[?]
Unit of Use DI Number: 84987350726977 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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