pH/pCO2/pO2/Na/K/Ca Analyzer 7005

GUDID 00386100003739

EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer

MEDICA CORPORATION

Ion-selective analyser IVD, automated
Primary Device ID00386100003739
NIH Device Record Keye3dbf205-f895-42d8-91a4-e01f1a37927b
Commercial Distribution StatusIn Commercial Distribution
Brand NamepH/pCO2/pO2/Na/K/Ca Analyzer
Version Model Number7005
Catalog Number7005
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
GS100386100003739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JFPElectrode, Ion Specific, Calcium

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/pCO2/pO2/Na/K/Ca Analyzer]

00386100003739EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer
00386100002596EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer

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