HARVEST®

GUDID 05020583514935

SmartPrep® 3 Multi-Cellular Processing System, Balance Weight/ tube Adapter TA-60

TERUMO BCT, INC.

Haematological concentrate system centrifuge
Primary Device ID05020583514935
NIH Device Record Key3fe1687d-b8f9-4acb-8eb2-04c55cd3062a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARVEST®
Version Model Number51493
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exempttrue
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
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
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
GS105020583514935 [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® ]

05020583514997SmartPrep® 3 Multi-Cellular Processing System, Red Cell Reduction Hardware Kit
05020583514935SmartPrep® 3 Multi-Cellular Processing System, Balance Weight/ tube Adapter TA-60
05020583514928TA-30 Balance Weight / Tube Adapter PRP30 BMAC®
05020583514898SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-30
05020583514836SmartPrep® 2 Centrifuge System
05020583514805SmartPrep® 3 Multi-Cellular Processing System
05020583514744SmartPRep® 2 Centrifuge System
05020583514720SmartPrep® 3 Multi-Cellular Processing System
05020583514034Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-20i PRP Procedure Pack
05020583514010Platelet Concentrate (PC) Procedure Pack
05020583514362Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-120n PRP Procedure Pack
05020583514157Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60n PRP Procedure Pack
05020583514140Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-30n PRP Procedure Pack
05020583514102LP-10 Clear PRP Kit
05020583514096Autologous Platelet Concentrate+ (APC) Procedure Pack, APC-120i PRP Procedure Pack
05020583514089Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-120 Procedure Pack
05020583514072Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60i PRP Procedure Pack
05020583514065Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60 Procedure Pack
05020583514058Autologous Platelet Concentrate+ (APC) Procedure Pack, APC-30i PRP Procedure Pack
05020583514041Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-30 Procedure Pack
05020583514027Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-20 Procedure Pack
05020583514478BBAN-10 Needles(BMAC/BMAC2)11Ga X 110mm
05020583514492Graft Delivery Pack
05020583514485BAN-25 8Ga BM Aspirate Needle
05020583514003Platelet Concentrate (PC) Procedure Pack, PC-30-01

Trademark Results [HARVEST]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HARVEST
HARVEST
98870891 not registered Live/Pending
SOKOLOVSKYI, DMYTRO
2024-11-25
HARVEST
HARVEST
98870891 not registered Live/Pending
HORDIICHUK, OLEKSANDR
2024-11-25
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
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