FDA.reportPublic FDA data

Ready Sensor™ Glucose Biosensor

Primary DI
00630414112343
Brand
Ready Sensor™ Glucose Biosensor
Company
Siemens Healthcare Diagnostics Inc.
Model
10320748
Catalog number
476378
Device description
In vitro diagnostics medical device. For measurement of glucose in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
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
K934907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934907000860 MEASURMENT SYSTEMCiba Corning Diagnostics Corp.1994-01-03CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414112343PrimaryGS10
00630414009469Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414112343006304141123436304141123430630414112343
00630414009469006304140094696304140094690630414009469

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
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 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
2
Lot or batch
true
Serial number
true

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00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
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