FDA UDI Not in Commercial Distribution 🇺🇸 United States

GENCHEM™ ISE Electrolyte Reference

DI: 00851445007259 · Model: GEN-ISE REFERENCE · GENCHEM INC
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GENCHEM™ ISE Electrolyte Reference
Primary DI
00851445007259
Version / Model
GEN-ISE REFERENCE
Catalog Number
GEN-ISE REFERENCE
Company Name
GENCHEM INC
Labeler DUNS
193856866
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-10
Public Version
4
Public Version Date
2022-10-21
Public Version Status
Update
Public Device Record Key
5b6c07cf-cdaf-4030-8e26-75bfb007fd0a
Distribution End Date
2020-08-19

Device Description

10/17/2022

Device Characteristics

Single Use
Yes
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
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
JFL PH RATE MEASUREMENT, CARBON-DIOXIDE
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM

GMDN Terms

Code Name
59238 Ion selective electrode (ISE) reference solution IVD, reagent

Identifiers

Type ID
Primary 00851445007259

Customer Contacts