pH Electrode 6201

GUDID 00386100002305

pH electrode for use with EasyBloodGas and EasyStat analyzers

MEDICA CORPORATION

Blood gas pH IVD, kit, ion-selective electrode (ISE)
Primary Device ID00386100002305
NIH Device Record Key8849640f-efcb-4a08-bc7b-4a63b2d12d91
Commercial Distribution StatusIn Commercial Distribution
Brand NamepH Electrode
Version Model Number6201
Catalog Number6201
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Operating and Storage Conditions

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
GS100386100002305 [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 Date2019-01-07
Device Publish Date2018-12-05

On-Brand Devices [pH Electrode]

00386100003142ISE pH electrode for use with EasyLyte Analyzers
00386100002305pH electrode for use with EasyBloodGas and EasyStat analyzers

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