FDA UDI Not in Commercial Distribution 🇺🇸 United States

HARVEST®

DI: 05020583514935 · Model: 51493 · TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HARVEST®
Primary DI
05020583514935
Version / Model
51493
Company Name
TERUMO BCT, INC.
Labeler DUNS
801679200
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-15
Public Version
7
Public Version Date
2023-09-11
Public Version Status
Update
Public Device Record Key
3fe1687d-b8f9-4acb-8eb2-04c55cd3062a
Distribution End Date
2023-02-14

Device Description

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

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
47154 Haematological concentrate system centrifuge

Identifiers

Type ID
Primary 05020583514935

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-40 – 66 Degrees Celsius