FDA.reportPublic FDA data

ROTO SILENTA 630 RS

Primary DI
04050674031134
Brand
ROTO SILENTA 630 RS
Company
Andreas Hettich GmbH
Model
ROTO SILENTA 630 RS, Solekühlung
Catalog number
5005-60
Device description
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate, nitrogen purging
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
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050674031134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674031134040506740311344050674031134

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
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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

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