FDA UDI In Commercial Distribution 🇺🇸 United States

PHOENIX DIAGNOSTICS, INC.

DI: 00853366007448 · Model: PH7000 · PHOENIX DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
PHOENIX DIAGNOSTICS, INC.
Primary DI
00853366007448
Version / Model
PH7000
Company Name
PHOENIX DIAGNOSTICS, INC.
Labeler DUNS
606814960
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-01-26
Public Version
4
Public Version Date
2020-12-21
Public Version Status
Update
Public Device Record Key
d7905d5c-7662-42ac-ae3b-bd3026b31dea

Device Description

Multi-Analyte Chemistry Calibrator (1-Point)

Device Characteristics

Single Use
Yes
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
JIX Calibrator, Multi-Analyte Mixture

GMDN Terms

Code Name
47868 Multiple-type clinical chemistry analyte profile IVD, calibrator

Identifiers

Type ID
Primary 00853366007448
Package 10853366007445