Na/K/Ca/pH Solution Pack 2123

GUDID 00386100003111

Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers

MEDICA CORPORATION

Multiple electrolyte IVD, calibrator
Primary Device ID00386100003111
NIH Device Record Key0f711187-c4a1-46ec-92a8-a610c120135a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNa/K/Ca/pH Solution Pack
Version Model Number2123
Catalog Number2123
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
GS100386100003111 [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

On-Brand Devices [Na/K/Ca/pH Solution Pack]

00386100003111Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers
00386100003067Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers

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