FDA.reportPublic FDA data

ROTIXA 500 RS

Primary DI
04050674075572
Brand
ROTIXA 500 RS
Company
Andreas Hettich GmbH
Model
ROTIXA 500, Standard
Catalog number
4950
Device description
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate
Published
2021-09-02
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
QBVCentrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBVCentrifuge For Preparation Of Cell Concentrate And/Or Plasma ConcentrateClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050674075572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674075572040506740755724050674075572

GMDN Terms#

Term, Definition table
TermDefinition
Blood bank centrifugeA freestanding mains electricity (AC-powered) device used mainly in a blood donor facility to process through centrifugal force (typically up to 10,000 rpm) a large volume of blood, usually to separate red blood cells or platelets from plasma for subsequent patient infusion, storage, or further processing. It is typically a large stationary structure with an electric motor, a shaft, a tachometer, and speed and time controls; it also includes a rotor for mounting one of several interchangeable heads with slots to fit sample holders (tubes/bags). Some types are available with refrigeration of the rotor chamber.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316403245
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
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
G0561068421PDQ Platelet CentrifugeBio/Data CorporationQBV2023-08-30
04050674076302ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674076326ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674076333ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674082532ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02