FDA UDI In Commercial Distribution 🇺🇸 United States

PHOENIX DIAGNOSTICS, INC.

DI: 00852676007759 · Model: 3-701 · PHOENIX DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
PHOENIX DIAGNOSTICS, INC.
Primary DI
00852676007759
Version / Model
3-701
Catalog Number
3-701
Company Name
PHOENIX DIAGNOSTICS, INC.
Labeler DUNS
606814960
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-15
Public Version
4
Public Version Date
2020-11-18
Public Version Status
Update
Public Device Record Key
b5d9765c-3ac9-4f9d-8d70-02457f51ec90

Device Description

Calibrator 1 for NuLyte Systems

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
JIX Calibrator, Multi-Analyte Mixture

GMDN Terms

Code Name
52867 Multiple electrolyte IVD, calibrator

Identifiers

Type ID
Primary 00852676007759
Package 10852676007756