Calcium Na/K/Ca/pH Analyzer 2016

GUDID 00386100002893

EasyLyte Calcium Na/K/Ca/pH Analyzer

MEDICA CORPORATION

Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD
Primary Device ID00386100002893
NIH Device Record Key9825a4bb-d353-4cf9-87a6-f24802c1ae4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalcium Na/K/Ca/pH Analyzer
Version Model Number2016
Catalog Number2016
Company DUNS112942404
Company NameMEDICA CORPORATION
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

Customer Support Contacts

Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100386100002893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-04
Device Publish Date2018-12-04

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