Hematocrit Control

GUDID 06944413802025

Edan Instruments, Inc.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID06944413802025
NIH Device Record Keyf6b81001-09df-439b-b546-21e12175c70e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHematocrit Control
Version Model NumberLow
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413802025 [Primary]
GS106944413807907 [Unit of Use]

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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