FDA.reportPublic FDA data

StatSpin

Primary DI
10873037000766
Brand
StatSpin
Company
IRIS INTERNATIONAL, INC.
Model
X00-003808-001
Catalog number
X00-003808-001
Device description
CritSpin Digital Reader
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JPIDevice, Hematocrit Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPIDevice, Hematocrit MeasuringHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10873037000766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1087303700076610873037000766

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVDA portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098240690
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10837461001973IRISpecCA/CB Twinset800-72112016-09-07
10837461002116iQ®200 iQ® Lamina™ Case of 4 x 7 L800-31022016-09-07
10837461008002AX-4280Specific Gravity Calibrator Set (NA)800-35172016-09-07
10837461002192iQ®200 iQ® Lamina™ Cradle800-31052016-09-07
10837461002529iChemiChem®10SG Urine Chemistry Strips800-70052016-09-07
10837461002536vChem®vChem®10 SG Urine Chemistry Strips800-70072016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10054749005519i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
00054749005512i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
00385480167291NOVANOVA BIOMEDICAL CORPORATIONJPI2017-04-24
00385480183420NOVANOVA BIOMEDICAL CORPORATIONJPI2017-04-24
10873037000216StatSpinBECKMAN COULTER IRELAND INC.JPI2016-09-24
04050674030410Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
04050674030427Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
04050674030441Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
04050674077675Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-22
00385480132114NovaNOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480141567NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480152150NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480239622STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480278034STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480322041STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480340816STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480347174STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480355360STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480380256STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539852NovaNOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539890NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539913NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539920NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480128827NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20