AccessGUDID - DEVICE: HARVEST® SmartPrep® (05020583514706)

GUDID

Device Identifier (DI) Information

Brand Name: HARVEST® SmartPrep®
Version or Model: 51470
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583514706
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: SmartPRep® 2 Centrifuge System, Two Place Rotor

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47154	Haematological concentrate system centrifuge	An electrically-powered device typically intended to be used at the point-of-care to concentrate platelets or bone marrow aspirate cells from a small volume of autologous (patient's own) blood/bone marrow using centrifugal force, for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). The concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. It includes a rotor head with a receptacle(s) for dedicated autologous specimen processing equipment. This device may additionally have refrigeration capabilities to perform temperature-sensitive procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQC	CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 66 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb7e11fc-755f-4eb8-a4de-7ba25c0075d5
Public Version Date: September 11, 2023
Public Version Number: 6
DI Record Publish Date: September 15, 2016