FDA.reportPublic FDA data

Rotor 24 place for capillaries

Primary DI
04050674077675
Brand
Rotor 24 place for capillaries
Company
Andreas Hettich GmbH
Model
1650-A
Catalog number
1650-A
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
04050674077675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674077675040506740776754050674077675

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
04050674030441Rotor 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