FDA UDI In Commercial Distribution 🇺🇸 United States

Kaluza C

DI: 15099590705138 · Model: Single User 1 Year Educational License · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Kaluza C
Primary DI
15099590705138
Version / Model
Single User 1 Year Educational License
Catalog Number
C10579
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-30
Public Version
2
Public Version Date
2022-03-22
Public Version Status
Update
Public Device Record Key
13ee94ce-aad4-46d5-9ee7-1ad05efa1ee9

Device Description

Kaluza C Single User 1 Year Educational License

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
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
JQP Calculator/Data Processing Module, For Clinical Use

GMDN Terms

Code Name
43472 Laboratory instrument/analyser application software IVD

Identifiers

Type ID
Primary 15099590705138