DEVICE: SCD Welding Wafer (35020583260314)

Device Identifier (DI) Information

SCD Welding Wafer
3NCC987
In Commercial Distribution

TERUMO BCT, INC.
35020583260314
GS1

70
801679200 *Terms of Use
3-NCC987 SCD Wafer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
36674 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.
Active false
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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 [?]
BK860041 0
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 54 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e070c8bc-93a5-4dca-b080-12e3f69462a1
May 29, 2025
2
May 14, 2025
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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
55020583260318 2 35020583260314 In Commercial Distribution
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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: 05020583260313 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(877)339-4228
FDAUDIprogram@terumobct.com
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