FDA UDI In Commercial Distribution 🇺🇸 United States

UniCel DxH

DI: 15099590192242 · Model: 600 · Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
UniCel DxH
Primary DI
15099590192242
Version / Model
600
Catalog Number
B23858
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
1f63a857-5512-4fbf-bc85-58e7db8a7b3b

Device Description

UniCel DxH 600 Coulter Cellular Analysis System

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 15099590192242