FDA.reportPublic FDA data

RAPIDLab® pH Electrode Fill

Primary DI
00630414115269
Brand
RAPIDLab® pH Electrode Fill
Company
Siemens Healthcare Diagnostics Inc.
Model
10311046
Catalog number
478533
Device description
pH Electrode Fill Solution (Pack of 3). An In vitro diagnostic medical device for use on RAPIDLab® series analyzers.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K935830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935830000CIBA CORNING 248 PH/BLOOD GAS ANALYZERCiba Corning Diagnostics Corp.1994-02-03CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414115269PrimaryGS10
00630414010069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414115269006304141152696304141152690630414115269
00630414010069006304140100696304140100690630414010069

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen (H+)/pH electrode IVDAn electrochemical sensor, also referred to as a calomel electrode, intended to be used to selectively measure electrical potential across a permeable membrane to determine the pH, or the concentration of hydrogen (H+) ions in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
3
Lot or batch
true
Expiration date on label
true

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