FDA.reportPublic FDA data

UNIVERSAL 320

Primary DI
04050674038393
Brand
UNIVERSAL 320
Company
Andreas Hettich GmbH
Model
1401-01
Catalog number
1401-01
Device description
bench-top centrifuge without rotor
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
GKGCentrifuge, Hematocrit
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKGCentrifuge, HematocritHematology2
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050674038393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674038393040506740383934050674038393

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose tabletop centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to separate the components of suspensions through low- or medium-speed centrifugal force (typically up to 6,000 or 12,000 rpm). It is typically a compact stationary structure with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. This device is mostly used to centrifuge various patient samples (i.e., body fluids), either alone or after addition of reagents or other additives before measuring analytes.

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

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