Platelet Additive Solution Connection Adapter 70070

GUDID 35020583700704

PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER

TERUMO BCT, INC.

Blood transfer set
Primary Device ID35020583700704
NIH Device Record Keya8cb15bf-eddd-4178-806c-2f0cb24b7c74
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlatelet Additive Solution Connection Adapter
Version Model Number70070
Catalog Number70070
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com

Device Identifiers

Device Issuing AgencyDevice ID
GS135020583700704 [Primary]

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-15
Device Publish Date2021-06-07

On-Brand Devices [Platelet Additive Solution Connection Adapter]

35020583700704PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER
05020583700703PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER

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