HARVEST®

GUDID 05020583514720

SmartPrep® 3 Multi-Cellular Processing System

TERUMO BCT, INC.

Haematological concentrate system centrifuge

• Primary Device ID: 05020583514720
• NIH Device Record Key: c06deb6b-2bd8-4cf6-a9d9-0246bb6031c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARVEST®
• Version Model Number: 51472
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(877)339-4228
• Email: FDAUDIprogram@terumobct.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583514720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK130068

FDA Product Code

• JQC: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-16
• Device Publish Date: 2016-09-15

On-Brand Devices [HARVEST® ]

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