FDA.report

ROTO SILENTA 630 RS

Primary DI
04050674031158
Brand
ROTO SILENTA 630 RS
Company
Andreas Hettich GmbH & Co. KG
Model
ROTO SILENTA 630 RS, Standard Hz/Kü
Catalog number
5005-50
Device description
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate, nitrogen purging
Published
2021-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050674031158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050674031158040506740311584050674031158

GMDN Terms

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

Regulatory Flags

DUNS number
316403245
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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