FDA.reportPublic FDA data

i-STAT

Primary DI
10054749000125
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
03P84-25
Catalog number
03P84-25
Device description
CREATININE 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
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGLElectrode, Ion Based, Enzymatic, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973292000I-STAT SYSTEMI-Stat Corp.1997-10-20CGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749000128PackageGS125In Commercial Distribution
10054749000125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749000128000547490001280547490001280054749000128
1005474900012510054749000125

GMDN Terms#

Term, Definition table
TermDefinition
Creatinine/ammonium electrode IVDAn electrochemical sensor in which an interaction between one or more immobilized enzymes (e.g., creatinine iminohydrolase) and creatinine occurs, developing an electrical potential or current proportional to the quantity of ammonium (NH4+) resulting from the reaction. The electrode may use one of several technologies (e.g., enzyme immobilized by adsorption) and mechanisms (e.g., diffusion of ammonium). It is used to measure creatinine in body fluids (e.g., urine).

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
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
10054749005519i-STATABBOTT POINT OF CARE INC.CGL2020-05-01
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSCGL2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSCGL2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSCGL2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSCGL2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSCGL2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSCGL2018-09-21
00385480183420NOVANOVA BIOMEDICAL CORPORATIONCGL2017-04-24
10385480433706STATSENSORNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
10385480528006STATSENSORNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480282413NOVANOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480422253StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480438063StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480440523StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480453356StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480486293StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480486309StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480506687StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480517560StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519946StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519953StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20