FDA UDI In Commercial Distribution 🇺🇸 United States

BC-RET Hematology Control

DI: 06944904031422 · Model: BC-RET · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BC-RET Hematology Control
Primary DI
06944904031422
Version / Model
BC-RET
Company Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Labeler DUNS
654671304
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-10-19
Public Version
1
Public Version Date
2023-10-27
Public Version Status
New
Public Device Record Key
25a2dfd5-3ddc-468f-ba35-02189a2e3c96

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JPK Mixture, Hematology Quality Control

GMDN Terms

Code Name
55866 Full blood count IVD, control

Identifiers

Type ID
Primary 06944904031422