SCD Welding Wafer

GUDID 55020583260318

3-NCC987 SCD Wafer

TERUMO BCT, INC.

Package sealing unit
Primary Device ID55020583260318
NIH Device Record Keye070c8bc-93a5-4dca-b080-12e3f69462a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCD Welding Wafer
Version Model Number3NCC987
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count70
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583260313 [Unit of Use]
GS135020583260314 [Primary]
GS155020583260318 [Package]
Contains: 35020583260314
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSBSet, Transfer (Blood/Plasma)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

Devices Manufactured by TERUMO BCT, INC.

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05020583910003 - COBE® 2991 2023-06-27 Blood Cell Processor
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05020583112209 - Spectra Optia® 2022-09-01 Single-Needle Connector
05020583122208 - Spectra Optia® 2022-09-01 Exchange Sets
05020583700703 - Platelet Additive Solution Connection Adapter2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER

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