HARVEST® SmartPrep®

GUDID 05020583514904

SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-60

TERUMO BCT, INC.

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Primary Device ID05020583514904
NIH Device Record Key05f28ca1-a401-440f-92ad-92c44ac91fef
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARVEST® SmartPrep®
Version Model Number51490
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583514904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-16
Device Publish Date2016-09-15

On-Brand Devices [HARVEST® SmartPrep® ]

05020583514980SmartPrep® 3 Multi-Cellular Processing System, 4 Place Process Disposable Holder
05020583514959SmartPrep® 3 Multi-Cellular Processing System, Four Place Rotor
05020583514942SmartPrep® 2 Centrifuge System, Two Place Rotor
05020583514911SmartPrep® 3 Multi-Cellular Processing System, TA 20
05020583514904SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-60
05020583514881SmartPrep® 3 Multi-Cellular Processing System, Balance Weight PRP 20 BMAC® BW-20
05020583514874SmartPrep® 3 Multi-Cellular Processing System, Rolling Cart 2
05020583514867SmartPrep® 3 Multi-Cellular Processing System, WS-2 Work Station 2 Cart
05020583514829SmartPrep® 2 Centrifuge System
05020583514782SmartPrep® 2 Centrifuge System, Two place rotor
05020583514751SmartPrep® 3 Multi-Cellular Processing System
05020583514706SmartPRep® 2 Centrifuge System, Two Place Rotor

Trademark Results [HARVEST]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HARVEST
HARVEST
98137998 not registered Live/Pending
Harvest LLP
2023-08-17
HARVEST
HARVEST
98031014 not registered Live/Pending
Genpak LLC
2023-06-07
HARVEST
HARVEST
97635492 not registered Live/Pending
Kruppa Enterprises LLC
2022-10-17
HARVEST
HARVEST
97485414 not registered Live/Pending
Guangzhou Jinglai Trading Co., Ltd.
2022-07-01
HARVEST
HARVEST
97467717 not registered Live/Pending
Kitchen Door Landscaping, LLC
2022-06-21
HARVEST
HARVEST
97278485 not registered Live/Pending
Williams, Cody
2022-02-22
HARVEST
HARVEST
97181099 not registered Live/Pending
HarperCollins Publishers L.L.C.
2021-12-20
HARVEST
HARVEST
97181038 not registered Live/Pending
HarperCollins Publishers L.L.C.
2021-12-20
HARVEST
HARVEST
90825073 not registered Live/Pending
Jackson, Jarvis
2021-07-13
HARVEST
HARVEST
90790228 not registered Live/Pending
Plastic Development Group LLC
2021-06-23
HARVEST
HARVEST
90571727 not registered Live/Pending
Jackson, Jarvis
2021-03-10
HARVEST
HARVEST
88775379 not registered Live/Pending
Plume Design, Inc.
2020-01-28
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