FDA UDI In Commercial Distribution 🇺🇸 United States

COULTER AcT

DI: 15099590576479 · Model: 5diff · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
COULTER AcT
Primary DI
15099590576479
Version / Model
5diff
Catalog Number
175356
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
6c04e078-1146-445e-9a3a-e8ce0bf2af3b

Device Description

COULTER Ac·T 5diff Autoloader Hematology Analyzer

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
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GKZ Counter, Differential Cell

GMDN Terms

Code Name
35476 Haematological cell analyser IVD

Identifiers

Type ID
Primary 15099590576479