FDA.reportPublic FDA data

Rotor 24 place for capillaries

Primary DI
04050674030441
Brand
Rotor 24 place for capillaries
Company
Andreas Hettich GmbH
Model
1650
Catalog number
1650
Device description
Hematocrit rotor, 24-place
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
04050674030441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674030441040506740304414050674030441

GMDN Terms#

Term, Definition table
TermDefinition
Microhaematocrit centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed 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
316403245
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050674084833Hematocrit capillaries207420742016-09-24
04050674011860Bucket136613662021-09-03
04050674022897Slide carrier2-place16702021-09-03
04050674022910Slide carrier1-place16622021-09-03
04050674024587Carrier4-place14672021-09-03
04050674026055Bucket4285-A4285-A2021-09-03
04050674026062Bucket4299-N4299-N2021-09-03
04050674026093Bucket425742572021-09-03
04050674026116Bucket429342932021-09-03
04050674026147Bucket425242542021-09-03
04050674026284Bucket142514252021-09-03
04050674026338Bucket142714272021-09-03
04050674026345Bucket145214522021-09-03
04050674026383Bucket166016602021-09-03
04050674026529Bucket175217522021-09-03
04050674026550Bucket509250922021-09-03
04050674026574Bucket505150512021-09-03
04050674026598Bucket168016802021-09-03
04050674026703Bucket139813982021-09-03
04050674026772Bucket1453-A1453-A2021-09-03

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
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
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