Calibrant Fluid Pack

GUDID 06944413803145

Edan Instruments, Inc.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Primary Device ID06944413803145
NIH Device Record Key9b5e775a-3bbe-41e6-8105-19d18bcf95b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalibrant Fluid Pack
Version Model NumberCP50
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 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
GS106944413802599 [Package]
Contains: 06944413803152
Package: [1 Units]
In Commercial Distribution
GS106944413803145 [Package]
Contains: 06944413802599
Package: [6 Units]
In Commercial Distribution
GS106944413803152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

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

On-Brand Devices [Calibrant Fluid Pack]

06944413803145CP50
06944413803107CP100

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