FDA UDI In Commercial Distribution 🇺🇸 United States

DxH Slidemaker Stainer II

DI: 15099590701567 · Model: C11477 · Beckman Coulter, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DxH Slidemaker Stainer II
Primary DI
15099590701567
Version / Model
C11477
Company Name
Beckman Coulter, Inc.
Labeler DUNS
008254708
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-03
Public Version
2
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
393295b1-5975-4fd2-ad9e-e027ecb299a9

Device Description

UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
KPA Slide Stainer, Automated
GKJ Spinner, Slide, Automated

GMDN Terms

Code Name
57871 Specimen processing instrument IVD

Identifiers

Type ID
Primary 15099590701567