HARVEST® SmartPrep®

GUDID 05020583514942

SmartPrep® 2 Centrifuge System, Two Place Rotor

TERUMO BCT, INC.

Haematological concentrate system centrifuge

• Primary Device ID: 05020583514942
• NIH Device Record Key: d7a2c95c-4eed-4808-bc41-cca8e4ec9ec3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARVEST® SmartPrep®
• Version Model Number: 51494
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 1
• DM Exempt: true
• 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
• 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
• 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	05020583514942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103340

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: 2019-12-12
• Device Publish Date: 2016-09-15

On-Brand Devices [HARVEST® SmartPrep® ]

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