FDA.reportPublic FDA data

StatSpin

Primary DI
10873037000216
Brand
StatSpin
Company
BECKMAN COULTER IRELAND INC.
Model
X00-004998-001
Catalog number
X00-004998-001
Device description
StatSpin MP Multipurpose Centrifuge
Published
2016-09-24
Public version status
Update
Distribution status
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
10873037000216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1087303700021610873037000216

GMDN Terms#

Term, Definition table
TermDefinition
Microhaematocrit centrifuge IVDAn electrically-powered device intended to be used for the processing of whole blood specimens using centrifugal force to determine the haematocrit, i.e., the ratio of red blood cell volume to whole blood volume expressed as a decimal, fraction, or percentage. The device typically requires a smaller sample volume than conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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15099590683245Navios EXACQUISITION NEW USER SOFTWARE V2.0 WIN 7B91237 2017-07-06
15099590683252Navios EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 B91238 2017-07-06
15099590683269Navios EXOFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7 B912392017-07-06
15099590683276Navios EXTETRA SOFTWARE V2.0 NEW USER B91240 2017-07-06
15099590671242DxH 500B40601B406012020-08-31
15099590679781DxH 520B406022019-03-22
10837461001065Iris660-3021660-30212025-04-16
10837461002321Iris800-3215800-32152025-04-16
15099590694968ClearLLab 10CB900022019-04-05
15099590694975ClearLLab 10CB900032019-03-26
15099590694982ClearLLab 10CB998832019-03-26
15099590701475ClearLLab 10CB968052019-03-26
15099590701482ClearLLab 10CB968062019-03-26
15099590701499ClearLLab 10CB968072019-03-26
15099590701505ClearLLab 10CB968082019-03-26

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
10873037000766StatSpinIRIS INTERNATIONAL, 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