Reference Electrode

GUDID 00811403015801

Diamond Diagnostics Inc.

Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD

Primary Device ID	00811403015801
NIH Device Record Key	7bb3a06e-abf3-4dca-9681-2d50c8fc0886
Commercial Distribution Status	In Commercial Distribution
Brand Name	Reference Electrode
Version Model Number	ME-2103D
Company DUNS	947514303
Company Name	Diamond Diagnostics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811403015801 [Primary]

FDA Product Code

JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-14
Device Publish Date	2023-06-06

On-Brand Devices [Reference Electrode]

00811403010448	To aide in measurements of Na+, K+, Cl-, Ca++, and Li+ in whole blood, plasma, serum and diluted
00811403015801	ME-2103D
00811403018772	AW-906179D
00811403017720	RD-945633D
00811403017713	RD-945389D
00811403011865	BM-373039D
00811403017089	OY-MU9197D
00811403013326	CD-476273D