Blood Gas and Chemistry Analyzer

GUDID 06944413801875

Edan Instruments, Inc.

Metabolic profile clinical chemistry analyser IVD, stationary, semi-automated
Primary Device ID06944413801875
NIH Device Record Key7299c48f-9aa8-4587-ba41-ba56822db901
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Gas and Chemistry Analyzer
Version Model Numberi15
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413801875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GLKControl, Hematocrit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

Devices Manufactured by Edan Instruments, Inc.

06944413815889 - Patient Monitor2024-06-25
06944413815896 - Patient Monitor2024-06-25
06944413815902 - Patient Monitor2024-06-25
06944413813977 - ECG cable2024-06-06
06944413813984 - ECG cable2024-06-06
06944413813991 - ECG cable2024-06-06
06944413814004 - ECG cable2024-06-06
06944413814011 - ECG cable2024-06-06

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