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ISE Sodium Electrode

Primary DI
04015630036189
Brand
ISE Sodium Electrode
Company
Roche Diagnostics GmbH
Model
4838084001
Catalog number
4838084001
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JGSELECTRODE, ION SPECIFIC, SODIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071211000COBAS C 111 ANALYZERRoche Diagnostics2007-07-30CIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630036189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630036189040156300361894015630036189

GMDN Terms#

Term, Definition table
TermDefinition
Sodium (Na+) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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