FDA.reportPublic FDA data

TB1 pO2/pCO2 Test/Blank Sensor

Primary DI
00630414515250
Brand
TB1 pO2/pCO2 Test/Blank Sensor
Company
Siemens Healthcare Diagnostics Inc.
Model
10316620
Catalog number
2195443
Device description
Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments
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
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002738000
K934907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002738000BAYER RAPIDPOINT 400 SYSTEMBayer Corp.2000-12-19CHL
K934907000860 MEASURMENT SYSTEMCiba Corning Diagnostics Corp.1994-01-03CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414515250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414515250006304145152506304145152500630414515250

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas/haemoximetry analyser IVD, point-of-careA mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.

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
1

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