FDA.reportPublic FDA data

i-STAT

Primary DI
10054749000163
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
03P88-25
Catalog number
03P88-25
Device description
CG8+ CARTRIDGE
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JFPElectrode, ion specific, calcium
JGSELECTRODE, ION SPECIFIC, SODIUM
JJEAnalyzer, chemistry (photometric, discrete), for clinical use
JPIDEVICE, HEMATOCRIT MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1
JPIDevice, Hematocrit MeasuringHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223710000
K230275000
K230285000
K230300000
K940918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223710000i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-07-28CGA
K230275000i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-10-27JGS
K230285000i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-10-27CHL
K230300000i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2023-10-27JFP
K940918000I-STAT 200 PORTABLE CLINICAL ANALYZERI-Stat Corp.1994-05-10CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749000166PackageGS125In Commercial Distribution
10054749000163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749000166000547490001660547490001660054749000166
1005474900016310054749000163

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)366-8020techsvc@apoc.abbott.com

Regulatory Flags#

DUNS number
079226216
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10054749005519i-STAT09P31-2609P31-262020-05-01
10054749000132i-STAT03P85-2503P85-252016-09-09
00054749004027i-STAT06F24-2006F24-202023-09-22
00054749001385i-STAT06F24-1606F24-162023-06-23
00054749004911i-STAT hs-TnI Calibration Verification, Levels 1-306P17-2006P17-202025-05-02
00054749004928i-STAT hs-TnI Control Level 106P17-2106P17-212025-05-02
00054749004935i-STAT hs-TnI Control Level 206P17-2206P17-222025-05-02
00054749004942i-STAT hs-TnI Control Level 306P17-2306P17-232025-05-02
10054749003058i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
00054749003051i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
10054749005779i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749005772i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749000661i-STAT06F14-0106F14-012023-06-23
10054749000071i-STAT03P79-2503P79-252016-09-09
10054749000149i-STAT03P86-2503P86-252016-09-09
10054749000170i-STAT03P89-2403P89-242016-09-09
10054749000187i-STAT03P90-2503P90-252016-09-09
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09
10054749000118i-STAT03P83-2503P83-252016-09-09

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