FDA.reportPublic FDA data

pH Electrode

Primary DI
00386100003142
Brand
pH Electrode
Company
MEDICA CORPORATION
Model
2151
Catalog number
2151
Device description
ISE pH electrode for use with EasyLyte Analyzers
Published
2018-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943091000EASY LYTE CALCIUM ANALYZERMedica Corp.1995-01-17JFP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100003142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100003142003861000031423861000031420386100003142

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory pH electrodeA clinical chemistry, electrolyte, electrode type biosensor, typically used in the laboratory for measuring pH. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-275-4892technicalsupport@medicacorp.com

Regulatory Flags#

DUNS number
112942404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00386100002084DBIL Reagent Kit 10212-410212-42019-02-14
00386100002107ALP Reagent Kit 10214-410214-42019-02-14
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00386100002138AMY Reagent Kit10217-410217-42019-02-14
00386100002169Mg Reagent Kit10220-410220-42019-02-14
00386100002176Phos Reagent Kit10221-410221-42019-02-14
00386100002183CK Reagent Kit 10222-410222-42019-02-14
00386100002190Iron (Fe) Reagent Kit10223-410223-42019-02-14
00386100002206LDL CHOL Reagent Kit 10224-410224-42019-02-14
00386100002213UALB Reagent Kit10225-410225-42019-02-14
00386100002237Lipase Reagent Kit 10227-410227-42019-02-20
00386100002244CRP Reagent Kit10228-410228-42019-02-14
00386100002268HbA1c Reagent Kit 10230-210230-22019-02-14

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