FDA.reportPublic FDA data

i-STAT

Primary DI
10054749005502
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
03P85-51
Catalog number
03P85-51
Device description
Cartridge, CG4+
Published
2020-10-05
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
CHLElectrode measurement, blood-gases (pco2, po2) and blood ph
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200492000i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-04-09CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749005505PackageGS125In Commercial Distribution
10054749005502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749005505000547490055050547490055050054749005505
1005474900550210054749005502

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

Contacts#

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

Regulatory Flags#

DUNS number
079226216
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10054749005519i-STAT09P31-2609P31-262020-05-01
10054749000163i-STAT03P88-2503P88-252016-09-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00054749005673i-STAT G3+ CartridgeAbbott Point of Care Inc.CHL2023-12-18
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480534437Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480563079Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574549Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574006Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2018-11-09
00385480578219Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2018-11-09
00385480583794Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2018-11-09
00385480586429Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2018-11-09
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807636GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807643GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807698GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807704GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807759GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807766GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807810GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
08426950807827GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TESTINSTRUMENTATION LABORATORY COMPANYKHP2018-01-24
00385480528559STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2017-07-06
00385480528566STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2017-07-06
00385480528566STAT PROFILENOVA BIOMEDICAL CORPORATIONKHP2017-07-06
00385480528573STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2017-07-06
00385480528573STAT PROFILENOVA BIOMEDICAL CORPORATIONKHP2017-07-06
00385480534185STAT PROFILENOVA BIOMEDICAL CORPORATIONCHL2017-07-06
00385480534185STAT PROFILENOVA BIOMEDICAL CORPORATIONKHP2017-07-06
00385480534208STAT PROFILENOVA BIOMEDICAL CORPORATIONKHP2017-07-06