FDA UDI In Commercial Distribution 🇺🇸 United States

Flow Check Pro

DI: 15099590205782 · Model: A63493 · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Flow Check Pro
Primary DI
15099590205782
Version / Model
A63493
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-28
Public Version
1
Public Version Date
2019-02-28
Public Version Status
New
Public Device Record Key
9b990f96-61d3-4edc-91f9-ba0d9776022a

Device Description

Flow-Check Pro Fluorospheres

Device Characteristics

Single Use
Yes
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PPM General Purpose Reagent

GMDN Terms

Code Name
55864 Non-blood cell primer/calibrator/control material IVD, reagent

Identifiers

Type ID
Primary 15099590205782